Who is the manufacturer of SOLID CLIP Single Use Clip Applier?

Medscope Biotech Co., Ltd. filed the 510(k) submission for SOLID CLIP Single Use Clip Applier (K221495).

What is the FDA product code for SOLID CLIP Single Use Clip Applier?

FZP. It is classified under 21 CFR 878.4300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for SOLID CLIP Single Use Clip Applier?

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

Who can help prepare an FDA 510(k) submission like SOLID CLIP Single Use 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.

SOLID CLIP Single Use Clip Applier

Q: What are the predicate devices for SOLID CLIP Single Use Clip Applier?

Endo Clip™ II Clip Applier (K143644).

K221495 · Medscope Biotech Co., Ltd. · FZP · Jul 18, 2024 · General, Plastic Surgery

Device Facts

Record ID	K221495
Device Name	SOLID CLIP Single Use Clip Applier
Applicant	Medscope Biotech Co., Ltd.
Product Code	FZP · General, Plastic Surgery
Decision Date	Jul 18, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.

Device Story

Sterile, single-use laparoscopic clip applier; consists of shaft (5mm or 10mm diameter, 33cm length), pistol-grip handle, actuation trigger, 360-degree rotation knob, and clip counter. Preloaded with titanium clips (Medium-Large or Large). Operated by surgeons during laparoscopic procedures. Squeezing trigger advances and forms titanium clip around vessel/tubular structure. Enables multiple clip applications without device withdrawal. Provides secure vessel ligation and radiographic marking. Benefits include reduced procedure time and improved surgical efficiency.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993), functional performance testing, animal testing, sterilization/stability validation (ISO 11135, ISO 11737, ISO 11607, ASTM F1140/F1929/F88/F1608), and MR compatibility assessment (ASTM F2052, F2213, F2182, F2119). All tests passed.

Technological Characteristics

Materials: Titanium clips. Dimensions: 330mm shaft length; 5mm or 10mm diameter. Mechanism: Mechanical pistol-grip trigger, 360-degree rotation. Sterilization: Ethylene Oxide. Standards: ISO 10993 (biocompatibility), ISO 11135 (sterilization), ISO 11607 (packaging), ASTM F2052/F2213/F2182/F2119 (MR compatibility).

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring dissection and ligation of blood vessels and tubular structures for radiographic marking. Contraindicated for contraceptive tubal occlusion and use on the central circulatory system, renal artery, iliac artery, or other vessels where metal ligating clips are not normally used.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

Endo Clip™ II Clip Applier (K143644)

Reference Devices

ENDO CLIPTM III 5mm Clip Applier (K121194)

Related Devices

K981239 — DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS · Deroyal Surgical · May 14, 1998
K964109 — MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP · Microsurge, Inc. · Nov 27, 1996
K040602 — SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS · Design Standards Corp. · May 10, 2004
K161758 — Weck Auto Endo10 Automatic Endoscopic Clip Applier · Teleflex Medical · Sep 7, 2016
K121194 — ENDO CLIP III 5MM CLIP APPLIER · Covidien · May 3, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration". July 18, 2024 Medscope Biotech Co., Ltd. Waine Su Sr. Regulatory Affairs Specialist 2F, No. 8, Keyi Street, GuangYuan Technology Park, Zhunan Town, Miaoli County, 35059 Taiwan Re: K221495 Trade/Device Name: SOLID CLIP™ Single Use Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: August 3, 2023 Received: August 3, 2023 Dear Waine Su: 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2024.07.18 11:44:44 --------------------------------------------------------------------------------------------------------------------------------------Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K221495 Device Name SOLID CLIP Single Use Clip Applier Indications for Use (Describe) The SOLID CLIP Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking. Type of Use (Select one or both, as applicable) | <div style="display:inline-block;"> <div style="display:inline-block;">Prescription Use (Part 21 CFR 801 Subpart D)</div> </div> | <div style="display:inline-block;"> <div style="display:inline-block;">Over-The-Counter Use (21 CFR 801 Subpart C)</div> </div> | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary K221495 # 1. SUBMITTER Medscope Biotech Co., Ltd. 2F, No.8, Keyi Street, Guang Yuan Technology Park, Zhunan Town, Miaoli County 35059, Taiwan Phone: +886-3-7580055 Fax:+886-3-7585050 Contact Person: Waine Su, Sr. Regulatory Affairs Specialist Email:wainesu@medscope.com.tw Date Prepared:July 08, 2024 #### 2. DEVICE | Device Name | SOLID CLIP™ Single Use Clip Applier | |------------------------|-------------------------------------| | Trade/Proprietary Name | SOLID CLIP™ | | Common Name | Clip Applier | | Regulation Number | 21 CFR 878.4300 | | Regulation Name | Implantable clip | | Regulatory Class | Class II | | Panel | General and Plastic Surgery | | Product Code | FZP | #### 3. PREDICATE AND REFERENCE DEVICES | Predicate Device | Endo Clip™ II Clip Applier, K143644 | |-------------------|-------------------------------------------| | Company Name | Covidien | | Reference Device | ENDO CLIPTM III 5mm Clip Applier, K121194 | | Company Name | Covidien | | Regulation Number | 21 CFR 878.4300 | | Product Code | FZP | {4}------------------------------------------------ #### 4. DEVICE DESCRIPTION The SOLID CLIP™ Single Use Clip Applier is a sterile, single patient use device designed for an appropriately sized trocar sleeve or larger sized trocar sleeve with the use of a converter. It consists of a shaft with an outer diameter of 10 or 5 mm and length of 33 cm, a jaw for forming ligating clips, a pistol handle, an actuation trigger, a 360 degrees rotational knob, and a clip counter. The shaft with outer diameter 10 mm was preloaded 10, 15, 20 ML (Medium-Large) or 10, 15 L (Large) titanium clips, outer diameter 5 mm shaft only preloaded 10, 15 ML (Medium-Large) titanium clips. Squeezing the trigger places a titanium clip in the jaws and closes the jaws to form the clip on the occlusion of the vessel or tubular structure. The design of SOLID CLIP™ Single Use Clip Applier provides secured placement of the clip to the targeted vessel and enables the surgeon to apply the clips during a laparoscopic procedure without the need for withdrawing and reinserting the device each time a clip is put in place and closed. | Series | Model No. | Shaft Length (mm) | Shaft Diameter (mm) | Clip Size | Clip Q'ty. | Clip Dimension (mm) | Image: Clip Dimension W | Image: Clip Dimension H | Image: Clip Dimension L | |--------|--------------|-------------------------|---------------------------|--------------|---------------|---------------------------|-------------------------|-------------------------|-------------------------| | | | | | | | W | H | L | | | CA16 | CA165 | 330 | 10 | L | 10 | 4.5 | 9.8 | 11 | | | | CA166 | 330 | 10 | L | 15 | 4.5 | 9.8 | 11 | | | | CA167 | 330 | 10 | ML | 15 | 4.5 | 7.8 | 9 | | | | CA168 | 330 | 10 | ML | 20 | 4.5 | 7.8 | 9 | | | | CA169 | 330 | 10 | ML | 10 | 4.5 | 7.8 | 9 | | | CA56 | CA567 | 330 | 5 | ML | 10 | 3.5 | 8.2 | 9 | | | | CA568 | 330 | 5 | ML | 15 | 3.5 | 8.2 | 9 | | ### 5. INDICATIONS FOR USE The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking. {5}------------------------------------------------ # 6. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE SOLID CLIP™ Single Use Clip Applier is compared to the predicate device, Endo Clip™ II Clip Applier (K143644) and also compared to ENDO CLIP™ III 5mm Clip Applier (K121194) which is used as a reference device specifically for its size. A side-by-side comparison conducted for clip applier performance demonstrates that SOLID CLIP™ Single Use Clip Applier is substantial equivalence to the subject device, the predicate device and the reference device. The subject device has the same intended use and similar technological characteristics with no new questions of safety or effectiveness raised. Detailed discussion is summarized in the below Comparison Charts that provide a side-by-side comparison. | Features | Subject Device | Predicate Device | Comparison | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Device Name | SOLID CLIP™ Single Use Clip Applier (K221495) | Endo Clip™ II Clip Applier (K143644) | | | Manufacturer | Medscope Biotech Co., Ltd. | Covidien | | | Regulation Number | 21 CFR 878.4300 | 21 CFR 878.4300 | Identical | | Regulation Name | Implantable clip | Implantable clip | Identical | | Regulatory Class | Class II | Class II | Identical | | Product Code | FZP | FZP | Identical | | Indications for use | The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing endoscopic procedures and can achieve occlusion of vessels and other tubular structures , and for radiographic marking. | The Endo Clip™ II Clip Applier has application in many types of endoscopic procedures to achieve occlusion of vessels and other tubular structures, and for radiographic markings. | Identical | | Contraindications | • The SOLID CLIP™ Single Use Clip Applier is not intended for contraceptive tubal occlusion, but may be used to achieve hemostasis following transection of the fallopian tube. • Do not use the SOLID CLIP™ Single Use Clip Applier on the central circulatory system, renal artery, iliac artery, or other vessels which metal ligating clips would not normally be used. | • The device is not intended for contraceptive tubal occlusion, but may be used to achieve hemostasis following transection of the fallopian tube. • Do not use the ENDO CLIP™ II disposable clip applier on the central circulatory system, renal artery, iliac artery, or other vessels which metal ligating clips would not normally be used. | Identical | | Description | • Sterile • Single patient use | • Sterile • Single patient use | Identical | | Features | Subject Device | Predicate Device | Comparison | | | Disposable | Disposable | | | Sterilization Process | Ethylene Oxide | Ethylene Oxide | Identical | | Shelf Life | 3 years | 5 years | Difference. Performing the shelf- life stability test has shown not to affect safety and performance. | | Technical specification | | | | | Shaft diameter | 10mm or 5mm | 10mm | Similar. 5mm was compared to the reference device | | Shaft length | 330mm | 290mm | Similar. Different design feature to transport the clips when firing the trigger | | Surgical field | 15° | 15° | Identical | | Configuration | Jaw, shaft, rotation knob, trigger, handle | Jaw, shaft, rotation collar, trigger, handle | Identical | | Handle and Trigger | Pistol-grip configuration with actuation trigger | Pistol-grip configuration with actuation trigger | Identical | | Shaft Rotation | 360-degree rotation knob in either direction | 360-degree rotation collar in either direction | Similar. Different mechanism, but the same purpose | | Clip Indicator | Yellow block appears when 5 or fewer clips remain in the device | Yellow bar which appears when the applier is empty | Similar. Different mechanism, but the same purpose | | Clip Material | Titanium | Titanium | Identical | | Clip Size & Quantity | ML : 10, 15, 20pcs; L : 10, 15pcs | ML : 20pcs | Similar. 5mm was compared to the reference device. Large size represents a larger clip length. | | Clip Open Width | 4.5mm | 4.5mm | Identical | | Clip Closed Length | ML: 9mm; L: 11mm | ML: 9mm | Similar. Large size represents a larger clip length. | | Clip Geometry | U-shape | U-shape | Identical | | Features | Subject Device | Predicate Device | Comparison | | | angle allows vessels to the back of the clip during approximation. | | | | Last Clip Lockout | Safety interlock feature. The trigger cannot be squeezed shut when the clip is empty to prevent empty jaw closure to damage a structure or vessel. | Safety-interlock handle design | Identical | | Performance | | | | | Clip Formation | Pass | Pass | Identical | | Clipped Gap | 0.17 mm | 0.18 mm | Similar | | Clipped Step Difference | 0.06 mm | 0.02 mm | Similar. All meet the criteria. | | Clipped Pull-out Force | 314 g | 258 g | Identical | | Clipped Slip Force | 884 g | 933 g | Similar. All meet the criteria. | | Airtight Capability | Pass | Pass | Identical | | Trigger Initial Force | 2.3 kg | 1.7 kg | Similar. All meet the criteria. | | Package | Blister with Tyvek lid | Blister with Tyvek lid | Identical | {6}------------------------------------------------ {7}------------------------------------------------ # 7. NON-CLINICAL TEST The following non-clinical tests were provided in support of the substantial equivalence determination. | No | Test Item | Reference Standard | Results | |----|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------| | 1 | Biocompatibility | ISO 10993 FDA guidance | Pass | | 2 | Performance Study (Functional Testing) | N/A | Pass | | 3 | Performance Study (Animal Testing) | FDA guidance | Pass | | 4 | Sterilization and Stability Testing | ISO 11135 ISO 11737-1 ISO 11737-2 ISO 11607-1 ISO 11607-2 ASTM F1140 ASTM F1929 ASTM F88 ASTM F1608 | Pass | {8}------------------------------------------------ | No | Test Item | Reference Standard | Results | |----|-----------------------------|------------------------------------------------------|---------------------------------------------------------------| | 5 | MR Compatibility Assessment | ASTM F2052 ASTM F2213 ASTM F2182 ASTM F2119 | MR safety information disclosed in the labeling and IFU | # 8. CONCLUSIONS The non-clinical data support SOLID CLIP™ Single Use Clip Applier with implantable titanium clip perform comparably to the predicate device and the reference device to demonstrate similar intended use and technological characteristics and can be able to achieve the same effectiveness and safety as the legally marketed predicate device (K143644).