Capio SLIM Suture Capturing Device

K172060 · Boston Scientific Corporation · PWI · Nov 3, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K172060
• Device Name: Capio SLIM Suture Capturing Device
• Applicant: Boston Scientific Corporation
• Product Code: PWI · Obstetrics/Gynecology
• Decision Date: Nov 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control. The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.

Device Story

Capio™ SLIM Suture Capturing Device is a sterile, single-use surgical instrument designed for use in open surgical procedures to facilitate suture placement in difficult-to-access locations. The device features a proximal one-hand-activated plunger, a tubular shaft, and a distal curved needle driver. Operation involves depressing the plunger to actuate the carrier, which drives a suture/dart through tissue; the needle is then automatically captured by a catch mechanism for retrieval or suture tying. The device is operated by a physician to assist in general suturing or the anchoring of urogynecologic surgical mesh. By automating the throw, catch, and retrieval of sutures in a single step, the device simplifies suture management, potentially reducing operative time and improving precision in tissue fixation.

Clinical Evidence

Bench testing only. Performance testing included sterilization validation, package integrity (dye penetration, seal strength), dimensional analysis, functional testing, mechanical stress testing (compression, tip tensile, side/top load deflection, needle retention, catch pull, actuation), distribution challenge, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity), and shelf-life testing. Results demonstrate the device is biocompatible and meets mechanical performance requirements.

Technological Characteristics

Materials: Plastic and stainless steel. Design: Tubular shaft with proximal plunger and distal curved needle driver. Energy: Manual actuation. Connectivity: None. Sterilization: Ethylene Oxide (EO). Shelf-life: 3 years. Single-use.

Indications for Use

Indicated for general surgical suturing and as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. Used with sensory and/or direct visual control.

Regulatory Classification

Identification

Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).

Special Controls

*Classification.* Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible; (2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed; (3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life; (4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and (5) Labeling must include: (i) Information regarding the mesh design that may be used with the device; (ii) Detailed summary of the clinical evaluations pertinent to use of the device; (iii) Expiration date; and (iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.

Predicate Devices

• Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System (K122459)

Submission Summary (Full Text)

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November 3, 2017

Boston Scientific Corporation Michelle Becker Regulatory Affairs Specialist Urology and Pelvic Health 100 Boston Scientific Way Marlborough, Massachusetts 01752

Re: K172060

Trade/Device Name: Capio™ SLIM Suture Capturing Device Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized surgical instrumentation for use with urogynecologic surgical mesh Regulatory Class: Class II Product Code: PWI Dated: September 29, 2017 Received: October 2, 2017

Dear Michelle Becker:

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. 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.

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

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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 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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# 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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## Indications for Use

510(k) Number (if known) K172060

Device Name Capio™ SLIM Suture Capturing Device

#### Indications for Use (Describe)

The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control.

The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size:20px">✖</span> </div> |
|----------------------------------------------|----------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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## 510(k) Summary for Capio™ SLIM Suture Capturing Device (K172060)

## A. Date Prepared

November 2, 2017

#### B. Sponsor

Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752

## C. Contact

Rachel Nankervis Specialist I, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail]

Or

Michelle Becker Principal Specialist, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail]

## D. Device Name

Trade Name: Capio™ SLIM Suture Capturing Device Common/usual Name: Suture Placement Device Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized surgical instrumentation for use with urogynecologic surgical mesh Classification: Class II Product Code: PWI

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## E. Predicate Device(s)

Trade Name: Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System Common/usual Name: Surgical Mesh for transvaginal pelvic organ prolapse repair Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Classification: II Product Code: OTP Premarket Notification: K122459

## F. Device Description

The Capio™ SLIM Suture Capturing Device is urogynecologic mesh instrumentation used with urogynecologic surgical mesh. The subject device is also intended for use in general suturing applications during surgery to assist in placement of suture material in tissues, and assist in insertion or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair.

The Capio™ SLIM Suture Capturing Device is a sterile, single use device and is designed to be used by the physician to facilitate the placement of sutures in difficult to access locations during open surgical procedures. The Capio™ SLIM device is also designed to throw, catch and retrieve sutures in one step. The device consists of a one-handactivated plunger at the proximal end, a tubular shaft and a curved needle driver at the distal end. Depressing the plunger actuates the carrier and drives the suture/dart through the tissue. The needle is automatically caught by the device's needle catch mechanism for easy suture tying, or the device may be re-loaded for additional suture throws.

#### G. Comparison of Intended Use with Predicate Device

| | K172060 (Subject Device) | K122459 (Predicate Device) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Capio™ SLIM Suture Capturing<br>Device is intended for use in general<br>suturing applications during surgery to<br>assist in the placement of suture<br>material in tissues at the operative site.<br>The Capio™ SLIM Suture Capturing<br>Device is to be used with sensory<br>and/or direct visual control.<br><br>The Capio SLIM Suture Capturing<br>Device is also intended for use as an | The Pinnacle Lite Pelvic Floor Repair<br>Kit is indicated for tissue reinforcement<br>in women with pelvic organ prolapse, for<br>transvaginal repair of posterior vaginal<br>vault prolapse.<br><br>The Uphold Lite Vaginal Support System<br>is indicated for tissue reinforcement in<br>women with pelvic organ prolapse, for<br>transvaginal repair of anterior and apical<br>vaginal vault prolapse |

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| aid in the insertion, placement, | |
|-----------------------------------------|--|
| fixation, or anchoring of surgical mesh | |
| during urogynecologic procedures. | |

The indications for use statements for subject device and the predicate device are not identical, as the predicate device is a surgical mesh that is indicated pelvic to treat organ prolapse. The intended use of the subject and predicate device is the same, as the subject device is an accessory to a surgical mesh.

| Device(s): | K172060 (Subject Device) | K122459 (Predicate Device) |
|--------------------------------|---------------------------------------------|---------------------------------------------------------------------|
| General Device Characteristics | | |
| Patient<br>contact | < 24 hours (tissue/bone) | Permanent (tissue/bone) |
| Operating<br>Principle | Aid in placement of surgical<br>mesh/suture | Transvaginal repair of anterior<br>and apical vaginal wall prolapse |
| Device<br>Design | Surgical mesh<br>instrumentation | Surgical mesh |
| Materials | Plastic<br>Stainless steel | Polypropylene |
| Shelf-life | 3 years | 3 years |
| Sterility | EO | EO |

## H. Comparison of Technological Characteristics

As discussed above. the subject device has different technological characteristics from the predicate device. The predicate device is a surgical mesh whereas the subject device is used for the placement of surgical mesh. Briefly, the predicate device differs from the subject device as follows:

- 1. Operating principle
- 2. Device Design
- 3. Materials

The differences between the subject device and the predicate device can raise different types of safety and effectiveness questions, as we are comparing an accessory and parent device. The differences in technological characteristics were evaluated through completion of special controls (performance testing, biocompatibility, shelflife/reprocessing, labeling, and sterilization) published in the final order reclassifying urogynecologic surgical mesh instrumentation from class I to class II published on January 6, 2017.

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#### I. Non-Clinical Performance Test Summary

The following tests were performed to demonstrate that the proposed Capio Slim Device met the applicable design and performance requirements and support a determination of substantial equivalence under the specified testing parameters. These tests include:

- Sterilization Validation
- . Package integrity testing following real-time aging
- o Dve Penetration
- o Seal Strength
- o Visual Inspection
- Dimensional Test ●
- Functional Test ●
- Compression Test
- Tip Tensile Test ●
- Side Load Deflection
- Top Load Deflection ●
- Needle Retention Test ●
- Catch Pull Test
- Actuation Test
- Distribution Challenge of Packaging
- Biocompatibility ●
- o Cytotoxicity
- o Sensitization
- Irritation or Intracutaneous Reactivity O
- o Acute systemic toxicity
- o Material-Mediated Pyrogenicity
- Shelf-life Testing ●

The results of performance testing demonstrate the Capio SLIM Suture Capturing Device is biocompatible, has sufficient mechanical performance for its intended use, and supports a three-year shelf life.

## J. Conclusion

The Capio SLIM is substantially equivalent and complies with the special controls outlined in 21 CFR 884.4910, Specialized surgical instrumentation for use with urogynecologic surgical mesh.