K140482 · Lake Region Medical · OCY · Apr 8, 2014 · Gastroenterology, Urology
Device Facts
Record ID
K140482
Device Name
MANDREL GUIDEWIRE
Applicant
Lake Region Medical
Product Code
OCY · Gastroenterology, Urology
Decision Date
Apr 8, 2014
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
Device Story
Mandrel Guidewires are medical devices used to facilitate the introduction of diagnostic and treatment instruments during gastroenterology and urology procedures. The device consists of a Nitinol or Stainless Steel core wire, tapered at the distal tip, with a secured distal coil. The coil may be composed of Stainless Steel, Palladium, Platinum, or Tungsten. The guidewire may include proximal core markers and is coated with PTFE or Silicone. The device is operated by clinicians in a clinical setting. It functions as a mechanical guide to assist in the placement of other medical devices. The addition of Tungsten as a coil material is the primary modification. The device is used to improve procedural access and navigation within the gastrointestinal or urological tracts, potentially benefiting the patient by enabling safer and more efficient delivery of diagnostic or therapeutic tools.
Clinical Evidence
Bench testing only. Testing included visual, dimensional, and mechanical attributes (e.g., torque strength, stiffness, lubricity, radiopacity, ISO strength of union, ISO flex, ISO corrosion, ISO fracture, and hydrodurability). Biocompatibility testing (cytotoxicity and hemolysis) confirmed the addition of Tungsten does not adversely affect safety. All verification and validation activities met predetermined acceptance criteria.
Technological Characteristics
Core wire: Nitinol or Stainless Steel. Distal coil: Stainless Steel, Palladium, Platinum, or Tungsten. Coating: PTFE or Silicone. Dimensions: 20cm to 500cm length; 0.014" to 0.35" diameter. Standards: ISO 10993 (biocompatibility), ISO 11070 (guidewire requirements), ISO 11135 (sterilization). Mechanical design: Tapered core with distal coil; straight or shaped tips.
Indications for Use
Indicated for patients undergoing gastroenterology and urology procedures requiring the introduction of diagnostic or treatment devices.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Lake Region
Medical
# SECTION 2.0 - 510(k) SUMMARY
September 24, 2014
This summary is being included in the Premarket Notification submission in lieu of a statement of availability.
| 2.1 MANUFACTURER / REGISTRATION INFORMATION | | |
|---------------------------------------------------------------------------------------------------------------|-----------------|--------------------------|
| Lake Region Medical | Telephone: | 952-448-5111 |
| 340 Lake Hazeltine Dr. | Fax: | 952-448-3441 |
| Chaska, Mn 55318 | Contact Person: | Mathew Pexa, |
| FDA REGISTRATION NUMBER: 2126666 | Title: | Regulatory Specialist II |
| 2.2 DEVICE TRADE NAME / PROPRIETARY NAME | | |
| Mandrel Guidewires or M-Wires | | |
| 2.3 DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES | | |
| ENDOSCOPE AND ACCESSORIES (OCY); 21 CFR Part 876.1500 | | |
| 2.4 CLASS OF DEVICE | | |
| These devices are Class II. | | |
| 2.5 IDENTIFICATION OF PREDICATE DEVICE(s) | | |
| K011084 Mandrel Guidewires (Lake Region Medical) | | |
| K080508 Mandrel Guidewires (Lake Region Medical) | | |
| 2.6 DEVICE DESCRIPTION | | |
| The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel | | |
| core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be | | |
| anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, | | |
| Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The | | |
| Mandrel guidewire family is bound by the following parameters: | |
|----------------------------------------------------------------|-----------------------------------------------|
| Lengths: | 20cm to 500cm |
| Outside Diameter: | 0.014" To 0.35" |
| Tips: | Straight or shaped with various flexibilities |
| Coil Length: | 2cm to 30cm |
#### 2.7 COMPLIANCE WITH APPLICABLE STANDARDS
LRM has determined that no mandatory standards, performance standards, or special controls have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic or by any subsequent regulatory action. However, the following standards are referenced within this filing: ISO 10993, ISO 11070, ISO 11135.
2.8 INTENDED USE STATEMENT
Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
NOTE: This modification does not alter its intended use.
2.9 CONTRAINDICATIONS
There are no contraindications listed.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2014
Lake Region Medical Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Drive Chaska, MN 55318
K140482 Re:
> Trade/Device Name: Mandrel Guidewire Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: March 11, 2014 Received: March 12, 2014
Dear Mathew Pexa,
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). and Cosmetic Hot (110. (110.) and the device, subject to the general controls provisions of the Act. The I ou may, dicrerere, manot of the Act include requirements for annual registration, listing of general connois provisions of rectice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. " Ne 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 finay be subject to additions, 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.
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Page 2 - Mathew Pexa
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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O I ake
PRODUCT: MANDREL GUIDEWIRE FAMILY w/ TUNGSTEN - Non-Vascular Use SUBMISSION DATE: February 12, 2014 SUBMISSION TYPE: SPECIAL 510(k)
## INDICATIONS FOR USE STATEMENT
..............................................................................................................................................................................
510(k) NUMBER (IF KNOWN): K140482
DEVICE NAME: Mandrel Guidewire
INDICATIONS FOR USE:
Mandrel guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
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PRESCRIPTION × USE
AND/OR .
R
OVER-THE-COUNTER USE
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S
2014.04.08 08:53:29 -04'00'
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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Healthcare. The logo consists of a red circular design on the left, followed by the words "Lake Region" in a bold, serif font. Below "Region" is the word "Medical" in a smaller font size. The logo is clean and professional, suggesting a healthcare organization.
### TECHNOLOGICAL CHARACTERISTICS 2.10
The design specifications are substantially equivalent to the existing Mandrel Guidewires. Material used for the coil of the guidewire will include the addition material option of Tungsten.
### 2.11 QUALITY SYSTEM CONTROL
### DESIGN CONTROLS
LRM is in conformance with the design control procedure requirements as specified in 21 CFR Part 820.33. Risk analysis was completed by means of a Failure Mode and Effects Analysis and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.
### MATERIALS / SUPPLIER / PRODUCT / PROCESS CONTROLS
LRM has formal quality systems in placed to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse effect on safety or effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size / group.
#### 2.12 QUALIFICATION TESTING
The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device.
### BENCH TESTING
In order to demonstrate equivalence of the guidewire, Lake Region Medical performed bench testing to establish requirements. Test devices were manufactured and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. The devices were then subjected to the following test methods to show the devices comply with the design input summary:
- Visual
- Radiopacity
- Lubricity
- J-Memory Test
- Body Stiffness
- Adhesion / Durability
- Guidewire Pull test
- · Torque Strength • Torque Control
- Dimensional • Linear Stiffness
- Lateral Stiffness
- Particulate Test
- ISO Strength of Union
- ISO Flex Test
- ISO Corrosion Resistance Test
- · ISO Fracture Test
- · Hydrodurability
- BIOCOMPATIBILITY TESTING
Biocompatibility testing per the design input summary requirements show the addition of Tungsten to the device does not affect the biocompatibility of the device is still in compliance with pre-defined acceptance criteria outlined in the product Design Input Summary. A biocompatibility risk assessment determined the following biocompatibility tests are required:
- · Cytotoxicity · Hemolysis
### 2.13 SUBSTANTIAL EQUIVALENCE DATA
The addition of Tungsten to the Mandrel guidewire family does not change the indications for use of the Mandrel guidewires and is not a change to the fundamental scientific technology. The information summarized above shows the device will perform as well as the previously marketed device.
