Who is the manufacturer of D-Clip; D-Clip Applier?

Peter Lazic GmbH filed the 510(k) submission for D-Clip; D-Clip Applier (K180757).

What is the FDA product code for D-Clip; D-Clip Applier?

HCH. It is classified under 21 CFR 882.5200 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for D-Clip; D-Clip Applier?

510(k) clearance (submission type: Traditional).

What are the predicate devices for D-Clip; D-Clip Applier?

L-Clip (K081489); Yasargil Aneurysm Clip (K081489); L-Clip Appliers (K081489); Yasargil Aneurysm Clip Appliers (K081489).

Who can help prepare an FDA 510(k) submission like D-Clip; D-Clip Applier?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

D-Clip; D-Clip Applier

K180757 · Peter Lazic GmbH · HCH · Apr 12, 2019 · Neurology

Device Facts

Record ID	K180757
Device Name	D-Clip; D-Clip Applier
Applicant	Peter Lazic GmbH
Product Code	HCH · Neurology
Decision Date	Apr 12, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5200
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Permanent D-Aneurysm-Clips are intended for permanent occlusion of cerebral aneurysms. Temporary D-Aneurysm-Clips are intended for temporary occlusion of intracranial blood vessels and cerebral aneurysms. The D-Aneurysm Clip Appliers are intended to be used for holding and applying D-Aneurysm-Clips. The D-Aneurysm Clip Appliers are not compatible with other systems.

Device Story

D-Aneurysm-Clips are titanium/titanium alloy implants used for permanent or temporary occlusion of cerebral aneurysms. Clips consist of two body parts and a spring; tension provides closing force. D-Aneurysm Clip Appliers (double-action or memory-effect versions) are used by neurosurgeons in clinical settings to grasp, open, guide, and apply clips to target tissue. Appliers function by compressing shanks to open jaws. Device is MR Conditional. Benefits include secure vessel occlusion during neurosurgical procedures. No energy source required.

Clinical Evidence

Bench testing only. Testing included microbiological qualification of gamma sterilization (SAL <10^-6), sterile barrier system validation, MRI safety (1.5T/3T), LAL endotoxin testing, and closing force degradation tests per ISO 9713. Applier performance validated via cleaning/disinfection efficiency (log reduction >4.8-6.8), steam sterilization (log reduction >12), and mechanical bending/cycling tests (100 cycles).

Technological Characteristics

Materials: Titanium (ISO 5832-2), Ti6Al4V (ISO 5832-3), 1.4021/1.4305/1.4310 stainless steels, Nitinol (ASTM F0263-05). Principle: Spring-loaded mechanical occlusion. Form factor: Standard/Mini sizes; straight/curved/angled/bayonet/fenestrated jaws. Sterilization: Gamma radiation (clips), steam (appliers). No energy source.

Indications for Use

Indicated for patients requiring occlusion of cerebral aneurysms or intracranial blood vessels. Intended for use by trained surgeons familiar with the surgical technique and use of these medical devices.

Regulatory Classification

Identification

An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.

Predicate Devices

L-Clip (K081489)
Yasargil Aneurysm Clip (K081489)
L-Clip Appliers (K081489)
Yasargil Aneurysm Clip Appliers (K081489)

Related Devices

K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS · Aesculap, Inc. · Jan 24, 2014
K991959 — PSI TITANIUM ANEURYSM CLIP · V. Mueller Neuro/Spine · Jan 6, 2000
K013136 — ANEURYSM CLIPS · Gistlstrasse · Nov 26, 2001
K983758 — YASARGIL TITANIUM ANEURYSM CLIPS · Aesculap, Inc. · Dec 18, 1998
K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS · Gimmi GmbH · May 6, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 12, 2019 Peter Lazic GmbH Sven Lazic Executive Vice President Immelmannweg 2 78532 Tuttlingen, Germany Re: K180757 Device Name: D-Aneurysm-Clips; D-Aneurysm Clip Appliers Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: Class II Product Code: HCH, HCI Dated: March 12, 2019 Received: March 15, 2019 Dear Sven Lazic: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database t identifies combination product submissions. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov 1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products'; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advices and CDRH Learn . Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure 2 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm 3 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ 4 http://www.fda.gov/Training/CDRHLearn {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "P" in gray, with a circular cutout in the upper right portion of the letter. To the right of the "P" is the name "PETER" stacked above "MICROSURGICAL INNOVATIONS" in gray. To the right of "PETER" is the name "LAZIC" in yellow. | DATE OF APPLICATION: | 04/09/2019 | |----------------------|-------------------------| | APPLICANT: | Peter Lazic GmbH | | | Immelmannweg 2 | | | D-78532 Tuttlingen | | | Germany | | | Tel: + 49 (7461) 966430 | | | Fax: +49 (7461) 8745 | | | E-Mail: info@lazic.de | | CONTACT PERSON: | Sven Lazic | Sver Executive Vice President Tel.: +49 (0)7461-96643-20 E-Mail: s.lazic@lazic.de {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "P" in gray, with a cutout circle in the upper right portion of the letter. Below the "P" is the name "PETER LAZIC" with "PETER" in gray and "LAZIC" in yellow. Underneath the name is the text "MICROSURGICAL INNOVATIONS" in a smaller, gray font. #### 1 Device Name | Trade Name of legally marketed devices: | L-Clip Yasargil Aneurysm Clip L-Clip Appliers Yasargil Aneurysm Clip Appliers | |-----------------------------------------|----------------------------------------------------------------------------------------| | Trade Name of modified device: | D-Aneurysm-Clips D-Aneurysm Clip Appliers | | Common Name: | Aneurysm Clip Aneurysm Clip Appliers | | Device Classification Name: | Aneurysm Clip Aneurysm Clip Appliers | #### Classification 2 Our aneurysm clips and aneurysm clip appliers are classified as follows: | Device: | D-Aneurysm-Clips | D-Aneurysm Clip Appliers | |------------------------|------------------|--------------------------| | Device description: | Aneurysm clip | Aneurysm clip applier | | Medical Specialty: | Neurology | Neurology | | Product Code: | HCH | HCI | | Regulation Number: | 882.5200 | 882.4175 | | Device Class: | 2 | 2 | #### Substantial Equivalence 3 The Lazic D-Aneurysm-Clip is substantial equivalent to the already cleared device of Lazic; the L-Clip and the Yasargil Aneurysm Clip. The Lazic D-Aneurysm Clip Applier is substantial equivalent to the already cleared device of Lazic; the L-Clip Appliers and the Yasargil Aneurysm Clip Appliers. #### Description of the Device 4 D-Aneurysm-Clips are available in two principle sizes (Standard and Mini) and several forms of jaws (straight, curved, angled, bayonet, fenestrated, non-fenestrated). Both sizes are available for permanent or temporary occlusion. D-Aneurysm Clip Appliers are designed to be used with both principle sizes of D-Aneurysm-Clips, Standard and Mini. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo for Peter Lazic Microsurgical Innovations. The logo features a large, gray letter "P" with a cutout in the upper right corner. Below the "P" is the name "PETER" in gray, followed by "LAZIC" in a yellow box. Underneath the name is the text "MICROSURGICAL INNOVATIONS" in a smaller font. # 4.1 Intended Use/Indications for Use #### 4.1.1 D-Aneurysm-Clips Permanent D-Aneurysm-Clips are intended for permanent occlusion of cerebral aneurysms. Temporary D-Aneurysm-Clips are intended for temporary occlusion of intracranial blood vessels and cerebral aneurysms. ### 4.1.2 D-Aneurysm Clip Appliers The D-Aneurysm Clip Appliers are intended to be used for holding and applying D-Aneurysm-Clips. The D-Aneurysm Clip Appliers are not compatible with other systems. # 4.2 Design ### 4.2.1 D-Aneurysm-Clip The D-Clip is manufactured out of three parts, two of those forming the body and one the spring. With D-Clip Appliers it is grasped from the outside to open, close and guide the clip. ### 4.2.2D-Aneurysm Clip Appliers The D-Clip Appliers exists in two versions: a version with double action handles and one version with memory effect. Both versions are applied the same way. Pressing the handle will open the jaw. #### 4.3 Material The D-Clip is made of Titanium according to ISO 5832-2 and Titanium alloy Ti6Al4V according to ISO 5832-3. #### 4.4 Usage/ Application #### 4.4.1 D-Aneurysm-Clip Both, the permanent and temporary D-Clips are intended for use by trained surgeons thoroughly familiar with the surgical technique and use of these medical devices. #### 4.4.2 D-Aneurysm Clip Appliers The D-Clip Applying Forceps serve for opening and closing the D-Clips. Using the forceps, the aneurysm clip is applied, repositioned or removed in the target tissue. The clip applying forceps have no function of their own and may only be used in combination with the suited D-Clips. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a gray letter "P" with the words "PETER LAZIC" in black text below it. To the right of "PETER" is a yellow rectangle that highlights the word "LAZIC". Below the name is the phrase "MICROSURGICAL INNOVATIONS" in a smaller, gray font. ### 4.5 Technological characteristics | Device | Primary Predicate Device | 510(k) Number | 510(k) Holder | |--------------------------|----------------------------------------------------|---------------|------------------| | D-Aneurysm-Clips | L-Clip Yasargil Aneurysm Clip | K081489 | Peter Lazic GmbH | | D-Aneurysm Clip Appliers | L-Clip Appliers Yasargil Aneurysm Clip Appliers | K081489 | Peter Lazic GmbH | # 4.5.1 Technological characteristics of D-Aneurysm-Clip | Technological characteristics | | K081489 | Change discussion | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Peter Lazic GmbH | Peter Lazic GmbH | | | | D-Aneurysm-Clips | Lazic L-Clips / Yasargil Aneurysm Clips | | | Design | D-clip: Outer application by the applying forceps Image: D-clip | L-clip: Inner application by the applying forceps Image: L-clip Yasargil: Outer application by the applying forceps Image: Yasargil clip | Compared to the L-clip the only difference is that the D-clip is applied from the outside. All other design features are identical. For both devices the same spring is used. Meaning they even share a semi- finished good. Compared to the Yasargil clip the D-clip has a similar outer application, but different spring design. Substantially Equivalent | | | --- | K081489 | Change discussion | | Technological characteristics | Peter Lazic GmbH | Peter Lazic GmbH | | | | Lazic D-Aneurysm-Clips | Lazic L-Clips / Yasargil Aneurysm Clips | | | Closing Force | Mini perm.: 110-130 gms Mini temp.: 70-90 gms Standard perm.: 150-180 gms Standard temp.: 90-130 gms Tolerance range: ± 7.5%, measured according to ISO 9713 | L-Clip: Mini perm .: 110-130 gms Mini temp.:70-90 gms Standard perm.: 150-180 gms Standard temp.: 90-130 gms Yasargil-Clip: Mini perm.: 110-130 gms Mini temp.:70-90 gms Standard perm.: 150-200 gms Standard temp.: 90-130 gms Tolerance range: ± 7.5%, measured according to ISO 9713 | The closing force of the D-Clip is identical to closing force of the L-Clip and lies in the range of Yasargil-Clip closing force. Substantially Equivalent | | Materials | Titanium ISO 5832-2 Ti6Al4V ISO 5832-3 | L-Clip: Titanium ISO 5832-2 Ti6Al4V ISO 5832-3 Yasargil-Clip: Ti6Al4V ISO 5832-3 Cobalt alloy Phynox ISO 5832-7 | D-Clip is manufactured from the identical materials than the Titanium Versions of the L-Clip and Yasargil Clip. Substantially Equivalent | | Energy source | No energy source needed | No energy source needed | No difference. Substantially Equivalent | | Principle of operation | Inside the body of the clip is a spring that creates tension and through this tension the necessary closing force for occlusion. With an applier, the jaws can be opened, closed and guided for occlusion. | Inside the body of the clip is a spring that creates tension and through this tension the necessary closing force for occlusion. With an applier, the jaws can be opened, closed and guided for occlusion. | No difference. Substantially Equivalent | | Technological characteristics | | K081489 | Change discussion | | | Peter Lazic GmbH | Peter Lazic GmbH | | | | Lazic D-Aneurysm Clip Appliers | Lazic L-Aneurysm Clip Appliers / Yasargil Aneurysm Clip Appliers | | | Design | One version with double action handles and one with memory effect. | One version with double action handles and one with memory effect. | Versions with double action handles and with memory effect of the D-Clip Appliers have identical shanks compared to those of the L-Clip and the Yasargil Clip. The difference of the three Appliers lies in the jaw design. When the shanks of the D-Clip Appliers and the Yasargil Clip Appliers are compressed, the jaws are closing making the clip open up. When the shanks of the L- Clip Appliers are compressed the jaws are opening up, making the clip open up. | | | | | Substantially Equivalent | | Materials | 1.4021 / ASTM A 276 / AISI 420A; 1.4305 / AISI 303; 1.4310 / AISI 301; 3.7165 / ASTM F 136 / ISO 5832-3; Nitinol / ASTM F0263-05 | 1.4021 / ASTM A 276 / AISI 420A; 1.4305 / AISI 303; 1.4310 / AISI 301; 3.7165 / ASTM F 136 / ISO 5832-3; Nitinol / ASTM F0263-05 | D-Clip Appliers are manufactured from the identical materials than the Titanium Versions of the L-Clip and Yasargil Clip Appliers. Substantially Equivalent | | Energy source | No energy source needed | No energy source needed | No differences Substantially Equivalent | {6}------------------------------------------------ # Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier 510(k) Premarket Notification Image /page/6/Picture/2 description: The image shows a logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "L" in gray, with a circular cutout in the upper portion. To the right of the "L" is the name "PETER LAZIC" in a sans-serif font, with "PETER" in gray and "LAZIC" in yellow. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, sans-serif font. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a large, gray letter 'P' with a circular cutout in the upper right corner. To the right of the 'P' is the name "PETER LAZIC" in a combination of gray and yellow text. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, gray font. ### 4.5.2 Technological characteristics of D-Aneurysm Clip Applier {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized gray letter "L" with a circular cutout, followed by the name "PETER LAZIC" in a stacked format. The "LAZIC" portion is highlighted with a yellow rectangle behind it. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, sans-serif font. | Technological characteristics | | K081489 | Change discussion | |-------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Peter Lazic GmbH | Peter Lazic GmbH | | | | Lazic D-Aneurysm Clip Appliers | Lazic L-Aneurysm Clip Appliers / Yasargil Aneurysm Clip Appliers | | | Applying Technique | Compressing clip shanks to open the clip from outer side of shanks. Image: Clip Applier | L-Clip Appliers: Compressing clip shanks to open the clip from inside of shanks. Image: L-Clip Applier Yasargil Aneurysm Clip Appliers: Compressing clip shanks to open the clip from outer side of shanks. Image: Yasargil Aneurysm Clip Applier | The applying technique of D-Clip Appliers and Yasargil Clip Appliers is identical. Compressing the clip shanks closes the jaws and opens the D-clip respective Yasargil Clip. Compressing the clip shanks of the L- Clip Appliers opens the jaws and that opens the L-Clip. Substantially Equivalent | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "L" in gray, with a circular cutout at the top. The words "PETER LAZIC" are printed in a smaller font size and are placed to the left of a yellow rectangle. Below the rectangle, the words "MICROSURGICAL INNOVATIONS" are printed in a smaller, gray font. The overall design is modern and professional. # 5 Performance Standards ### 5.1 D-Aneurysm-Clips | Test | Test Method Summary | Results | |----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Microbiological performance qualification of gamma radiation sterilization | 10 samples of the worst case clips were tested. The verification dose was determined based on the average bioburden of three lots as $5,2\pm0,52$ kGy. The 10 samples were gamma irradiated. | An average bioburden of 2,0 cfu/sample was determined after sterilization. The tests indicated that the microbial contamination was inactivated by the irradiation of $5,40$ kGy $\pm$ $3,7$ %. Therefore, the gamma irradiation method ensures effective conditions with a sterility assurance level (SAL) <10-6 for the sterilization of the devices by application of a minimum dose of $25$ kGy. The tests were conducted on a worst case clip. The worst case analysis covers the predicate device as well as the D-Clip. The results show that it is possible to sterilize the D-Clip with an identical sterilization dose than the predicate device. | | Validation of the sterile barrier system (SBS)) | A validation of the sterile barrier system has been conducted by the responsible service provider. A basic stability study of the empty SBS as well as stability studies and performance testing of the SBS with products was conducted. | The requirements imposed on microbial barrier properties for the basic SBS were met successfully for the packaging material. Shelf life of the sterile barrier system after 5 years accelerated aging was confirmed successfully. | | MRI Safety | The devices had been tested in a static magnetic field of 1,5 and 3- Tesla and a maximum spatial gradient magnetic field of 4,000- Gaus/cm. | The testing demonstrated that the D-Clip and the predicate device are MR Conditional. They will not present an additional hazard or risk to a patient undergoing an MRI procedure in a static magnetic field of 1.5- Tesla and 3-Tesla, with a maximum spatial gradient magnetic field of 4,000-Gauss/cm. A maximum whole body averaged specific absorption rate of 2-W/kg for 15 minutes of scanning in the Normal Operating Mode was measured. These parameters are equivalent for the D-Clip and the L- Clip. The D-Clip is expected to produce a maximum temperature rise of 1,7°C after 15-minutes of continuous scanning. The L-Clip is expected to produce a maximum temperature rise of 1,8°C after 15- minutes of continuous scanning. The D-Clip extends approximately 10-mm from this implant when imaged using a gradient echo pulse | | | | sequence and a 3-Tesla MR system, while the L-Clip extends approximately 15-mm. The results for the D-Clip outperform those for the predicate device. | | LAL endotoxin test | The samples were rinsed with sterile, pyrogen free water according to the product- and method-specific validation. Then, the rinsing fluids were investigated for the presence of endotoxins with the quantitative LAL endotoxin test. Sterile, pyrogen free water was used as negative control, FDA proved endotoxin standard as positive control. | Endotoxins were not detected in the rinsing fluids of the investigated samples. The test has been performed on the predicate device. Since the devices are manufactured with similar manufacturing processes and identical materials the results are deemed applicable. | | Degradation of closing force tests | The closing force of the clip shall be measured before and after 10 maximum opening of the clip with the recommended applier. The reduction of the closing force shall be less than 5% of the nominal closing force. | The tested D-Clips did fulfill the requirements of ISO 9713. The test results of the L-Clips and the Yasargil Clips fulfilled the requirements as well. The closing force is deemed equivalent. | {10}------------------------------------------------ # Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier 510(k) Premarket Notification Image /page/10/Picture/2 description: The image shows a logo for Peter Lazic Microsurgical Innovations. The logo features a gray letter "P" with a circular cutout in the upper right corner. Below the "P" is the name "PETER LAZIC," with "PETER" in gray and "LAZIC" in yellow. Underneath the name, in smaller gray font, are the words "MICROSURGICAL INNOVATIONS." ### 5.2 D-Aneurysm Clip Appliers | Test | Test Method Summary | Results | |-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Microbiological efficiency control of the automated cleaning and disinfection method | For determination of the cleaning efficiency selected reference products were contaminated with "British Soil" containing spores of Bacillus atrophaeus. For determination of the disinfection efficiency, selected reference products were contaminated with a suspension of the high-resistant test organism Mycobacterium terrae. Then, according to the instructions of the sponsor the automated cleaning and disinfection method was performed on three contaminated reference products. Afterwards, the reduction of the | A worst-case selection has been conducted identifying several critical components. A dummy device including the critical components was manufactured and used for all reprocessing validations. The concentration of the used test organisms Bacillus atrophaeus was reduced by the automated cleaning method of at least 5.2 log steps. The concentration of the used test organism Mycobacterium terrae was reduced of at least 6.8 log steps. | | | test organisms was determined. | The tests had been conducted with the predicate device. The before described worst-case dummy has more or identical disadvantageous properties with regard to product geometry and surface structure. Therefore the D-Clip appliers are deemed to be able to be cleaned and disinfected equivalent to the predicate device. | | Microbiological efficiency control of the manual cleaning and disinfection method | For determination of the cleaning efficiency selected reference products were contaminated with "British Soil" containing spores of Bacillus atrophaeus. For determination of the disinfection efficiency, selected reference products were contaminated with a suspension of the high-resistant test organism Mycobacterium terrae. Then, according to the instructions of the sponsor the manual cleaning and disinfection method was performed on three contaminated reference products. Afterwards, the reduction of the test organisms was determined. | Visible remains of the contamination medium were not detected on the reference devices after performance of the manual cleaning method. The concentration of the used test organisms Bacillus atrophaeus was reduced by the manual cleaning method of at least 4.8 log steps. The concentration of the used test organism Mycobacterium terrae was reduced of at least 5.3 log steps. The tests had been conducted with the predicate device. The before described worst-case dummy has more or identical disadvantageous properties with regard to product geometry and surface structure. Therefore the D-Clip appliers are deemed to be able to be cleaned and disinfected equivalent to the predicate device. | | Microbiological efficiency control of steam sterilization | Three qualification runs with three inoculated test samples each were conducted. The first and third run was conducted with sterilization temperature 121°C, exposure time 10min (half cycle) and the second run with sterilization temperature 132°C, exposure time 1,5min (half cycle). For each qualification run one non-exposed process challenge device per type was used as control for spore viability. For inoculation the most difficult parts for steam access were used. The Type A1 challenge devices were inoculated at the joint of the forceps, at the annular gap of the shaft and at the gap between spring and handle. The Type A2 challenge devices were inoculated at the joint of the forceps, at the annular gap of the shaft and at the joint of the handle. The Type A3 challenge devices were inoculated at the front, the central and the back of the cross armed joint. | All tested devices in three independent half cycle qualification runs were free of microbial growth. The conducted tests indicate that the products of the product group Applying Forceps of Peter Lazic can be steam-sterilized with a sufficient spore log reduction of >12 by use of standard sterilization parameters (fractioned vacuum procedure, 121°C, 20 min, and 134°C, 4min). The tests had been conducted with the predicate device. The before described worst-case dummy has more or identical disadvantageous properties with regard to steam access, steam permeability and product geometry than the D-Clip appliers. Therefore the D-Clip appliers are deemed to be able to be sterilized equivalent to the predicate device. | | Bending test Memory material in straight condition at the beginning of use/ -without wash-out and cleaning cycles- | The test was determined to show via three point bending procedure how much force is necessary to bend the shaft. The tests had been conducted on the raw material with mechanical force. First the force to bend the product was measured as well as the maximum radius and angle. Then | About 40 N were necessary to deform the shaft, meaning it takes force to deform the shaft, but the shaft can be deformed without much effort. The material can be bend by hand without much effort. The test also shows that the material properties have not changed after a certain time. | | | the material was bend 100 times, | The force required to bend the shaft was in a similar range after | | | measuring the bending force again after 100 bendings. | 100 bends. This means that bending has no effect on the material and its properties. Therefore, the material has no negative effect on the device. | | Defining the bending cycles to possible function restrictions | The aim of the test is to find out whether applying forceps with memory shaft shows possible functional limitations after bending some times. 10 applying forceps are bent several times without heating and regenerating the shaft in between. The bending is done manually and without exact determination of the bending angle, as it is the case in operations. The procedure is as follows, the appliers are checked for functions in their original steps with zero bendings. Then the shaft is bent over 90° and the appliers are checked for their functions. In the next step the shaft is straightened, and the appliers are checked for their functions. 30 repetitions are performed (15 times 90° bending, 15 times straightening) | The results were positive without exception. After 30 repetitions all applying forceps were still functioning as intended. The bending did not have an influence on the function of the applier. They still fulfilled the technical requirements. | | Behavior of the D-Clip Applying forceps after repeated use and reprocessing | For this test 10 D-Clips appliers were produced. In the test the use and reprocessing of the device was simulated. Therefore, the Items were bend 10 times, then cleaned in an ultrasonic bath (simulating a manual cleaning) and then sterilized at 134°C for 12 minutes. This procedure was performed 100 times. | All 10 tested Memory D-Aneurysm- Clip Appliers showed full function after the maximum tested 100 cycles. All Memory-Clip Appliers were tested according To the testing for product release and fulfilled the specification. Therefore, we can tell that the bending of the shaft within 100 times max. bending does not have effects on the function of the D-Clip Memory applier. | {11}------------------------------------------------ ## Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier 510(k) Premarket Notification Image /page/11/Picture/2 description: The image contains a logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "L" in gray, with the words "PETER LAZIC" in a smaller font below it. To the right of "LAZIC" is a yellow rectangle. Below the letter and name is the text "MICROSURGICAL INNOVATIONS" in a smaller, sans-serif font. The overall design is clean and modern, suggesting a professional and innovative company. {12}------------------------------------------------ # Peter Lazic GmbH D-Aneurysm-Clip & D-Aneurysm Clip Applier 510(k) Premarket Notification Image /page/12/Picture/2 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter "P" in gray, with the words "PETER LAZIC" in a smaller font below it. The word "LAZIC" is highlighted in yellow. Below the name, the words "MICROSURGICAL INNOVATIONS" are written in a smaller, gray font. The logo is clean and modern, suggesting a focus on precision and innovation. # 6 Sterilization Lazic's D-Aneurysm-Clips are available in sterile conditions. Lazic's D-Aneurysm Clip Appliers are available in non-sterile conditions only. {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the logo for Peter Lazic Microsurgical Innovations. The logo features a stylized letter 'P' in gray, with a small white circle cut out of the top right corner. To the right of 'P' is the name 'PETER LAZIC' with 'PETER' stacked on top of 'LAZIC'. The word 'LAZIC' is in yellow. Below the name is the text 'MICROSURGICAL INNOVATIONS' in a smaller, sans-serif font. #### Conclusion 7 The modification of Lazic's D-Aneurysm-Clips raises no new questions of safety and effectiveness. It combines the design of the L-Clip with the application of the Yasargil Aneurysm Clip. The same applies to Lazic's D-Aneurysm Clip Appliers. Therefore, the D-Aneurysm-Clips and the D-Aneurysm Clip Appliers are substantially equivalent to the predicate devices. {14}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.