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 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.

AI/ML Overview

This document is a 510(k) summary for a medical device (Capio™ SLIM Suture Capturing Device) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study that proves the device meets specific acceptance criteria in the way a clinical or performance study of an AI/imaging device would.

Based on the provided text, here is an analysis regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria":

This document does NOT describe the acceptance criteria or a study proving device performance in the context of an AI/imaging diagnostic device.

Instead, it describes the non-clinical performance tests conducted to demonstrate that the device meets applicable design and performance requirements and supports substantial equivalence to a predicate device. The "acceptance criteria" in this context refer to the successful completion and passing of these engineering and safety tests.

Here's how to interpret the request with the provided information:

1. A table of acceptance criteria and the reported device performance

The document lists various non-clinical performance tests. For each test, the "reported device performance" is implicitly that the device passed or met the requirements, thus demonstrating sufficient performance for its intended use and compliance with special controls. Specific numerical criteria or results are not provided for each test in this summary.

Acceptance Criteria (Test)	Reported Device Performance (Implied)
Sterilization Validation	Validated
Package integrity testing (real-time aging):	Passed (Dye Penetration, Seal Strength, Visual Inspection)
Dye Penetration	Passed
Seal Strength	Passed
Visual Inspection	Passed
Dimensional Test	Met specifications
Functional Test	Met specifications
Compression Test	Met specifications
Tip Tensile Test	Met specifications
Side Load Deflection	Met specifications
Top Load Deflection	Met specifications
Needle Retention Test	Met specifications
Catch Pull Test	Met specifications
Actuation Test	Met specifications
Distribution Challenge of Packaging	Passed
Biocompatibility:	Biocompatible (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity)
Cytotoxicity	Non-cytotoxic
Sensitization	Non-sensitizing
Irritation or Intracutaneous Reactivity	Non-irritating
Acute systemic toxicity	Non-toxic
Material-Mediated Pyrogenicity	Non-pyrogenic
Shelf-life Testing	Supports a three-year shelf life

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The tests described are primarily engineering, mechanical, and biological tests on device prototypes or manufactured units, not on a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The ground truth for these non-clinical tests is based on established engineering standards, material science, and biological testing protocols, not expert medical opinion on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or uncertain diagnoses, which is not the case for these non-clinical device tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This device is a physical surgical instrument, not an AI or imaging device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

There was no standalone (algorithm only) performance study done. This device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained previously, for the non-clinical tests, the "ground truth" is based on:

Engineering standards and specifications: For dimensional, functional, compression, tensile, deflection, needle retention, catch pull, and actuation tests.
Established protocols for sterilization and packaging integrity: For sterilization validation, package integrity, and distribution challenge tests.
Standardized biocompatibility test methods: For cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
Industry standards for accelerated and real-time aging: For shelf-life testing.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/machine learning device.

In summary, the provided document describes the engineering, mechanical, sterility, packaging, and biocompatibility performance data for a physical surgical device, demonstrating that it meets design requirements and supports substantial equivalence. It does not contain information typically associated with clinical studies or AI device performance evaluation.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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)	✖
Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 508-683-4755 Fax: 508-683-5041 Rachel.Nankervis@bsci.com

Michelle Becker Principal Specialist, Regulatory Affairs Phone: 508-210-6988 Fax: 508-683-5041 Michelle.Becker@bsci.com

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

G. Comparison of Intended Use with Predicate Device

	K172060 (Subject Device)	K122459 (Predicate Device)
Indicationsfor Use	The Capio™ SLIM Suture CapturingDevice is intended for use in generalsuturing applications during surgery toassist in the placement of suturematerial in tissues at the operative site.The Capio™ SLIM Suture CapturingDevice is to be used with sensoryand/or direct visual control.The Capio SLIM Suture CapturingDevice is also intended for use as an	The Pinnacle Lite Pelvic Floor RepairKit is indicated for tissue reinforcementin women with pelvic organ prolapse, fortransvaginal repair of posterior vaginalvault prolapse.The Uphold Lite Vaginal Support Systemis indicated for tissue reinforcement inwomen with pelvic organ prolapse, fortransvaginal repair of anterior and apicalvaginal 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
Patientcontact	< 24 hours (tissue/bone)	Permanent (tissue/bone)
OperatingPrinciple	Aid in placement of surgicalmesh/suture	Transvaginal repair of anteriorand apical vaginal wall prolapse
DeviceDesign	Surgical meshinstrumentation	Surgical mesh
Materials	PlasticStainless 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
1. Device Design
1. 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.

Regulation Number and Section

§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.

(a)
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).(b)
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.