The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester and polyethylene suture through soft tissue in endoscopic and other limited access procedures.

Device Description

The Opus® SmartStitch™Suture Device with PerfectPasser is designed to allow the surgeon the option to place a simple stitch or a mattress stitch through soft tissue in endoscopic and other limited access procedures.

AI/ML Overview

The provided document is a 510(k) summary for the Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study with detailed statistical analysis.

Therefore, many of the requested elements (like acceptance criteria, sample sizes for test sets, ground truth establishment methods, MRMC studies, or training set details) are not applicable or not provided in this type of regulatory document.

Here's the breakdown of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device.
Reported Device Performance: Not reported in terms of specific performance metrics or clinical outcomes. The document states that the "modification incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with PerfectPasser Connector" and "the device, as designed, is as safe and effective as the predicate device." This is the core "performance" claim for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable / Not provided. A formal "test set" in the context of an algorithm or statistical study proving performance is not detailed in this 510(k) submission. The submission is based on demonstrating equivalence, not on a new, comprehensive clinical performance study. There's no mention of specific data or its provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable / Not provided. As there's no defined "test set" and a requirement to establish ground truth for it, this information is not present.

4. Adjudication Method for the Test Set:

Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No. This document does not describe an MRMC comparative effectiveness study.

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

Not applicable. This device is a surgical instrument (suture device), not an algorithm or AI. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

Not applicable / Not provided. The device is a physical surgical tool; the concept of "ground truth" as used for AI/algorithm validation doesn't apply directly here. The "proof" for substantial equivalence relies on comparing the device's design, materials, and intended use against a previously cleared device.

8. The Sample Size for the Training Set:

Not applicable / Not provided. This is not an AI/ML device, so there is no training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not provided.

Summary of the Study (as described in the 510(k)):

The "study" presented in this 510(k) is a substantial equivalence comparison to a predicate device, rather than a de novo clinical trial or performance study.

Predicate Device: Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector (K062244, Cleared 10/02/06).
Nature of the "Study": The submission argues that the modified device is substantially equivalent because it "incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with PerfectPasser Connector."
The "primary difference includes the addition of a material." The document asserts that this difference "does not raise any questions regarding the safety and effectiveness" and that "the materials are well characterized."
Conclusion of the "Study": The device, as designed, is "as safe and effective as the predicate device."

This document primarily focuses on regulatory approval by demonstrating that a modified version of an already approved device remains safe and effective relative to its predicate, rather than providing detailed performance metrics from a new, extensive study.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ArthroCare Corporation Ms. Laura N. Kasperowicz Sr. Manager. Regulatory Affairs 15285 Alton Parkway, #200 Irvine, CA 92618

JUL 2 7 2015

Re: K070671

Trade/Device Name: Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): March 9, 2007 Received (Date on orig SE Itr): March 12, 2007

Dear Ms. Kasperowicz,

This letter corrects our substantially equivalent letter of April 6, 2007.

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

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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 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 contact 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. 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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ArthroCare Corporation Opus SmartStitch Suture Device Special Premarket Notification March 9, 2007

INDICATIONS FOR USE STATEMENT

510(k) Number: K 070671

Opus SmartStitch™ Suture Device with PerfectPasser™ Connector Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) X

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) NO

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) Division of General, Restorative, and Neurological De 510(k) Number

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K070671

ArthroCare Corporation Opus SmartStitch Suture Device Special Premarket Notification March 9, 2007

510(K) SUMMARY

ARTHROCARE CORPORATION

OPUS SMARTSTITCH SUTURE DEVICE WITH PERFECTPASSER

APR - 6 2007

General Information

Submitter Name/Address:	ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-3523
Establishment Registration No.:	2951580
Contact Person:	Laura N. KasperowiczSr. Manager, Regulatory Affairs
Date Prepared:	March 9, 2007
Device Description
Trade Name:	Opus® SmartStitch™ Suture Device
Generic/Common Name:	Endoscopic suture device
Classification Name:	Endoscope and accessories(Class II per 21 CFR 876.1500)
Product Code:	KOG
Predicate Device
Opus SmartStitch Suture Device	K062244 (Cleared 10/02/06)

Product Description

Indications For Use

The Opus SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester or polyethylene suture through soft tissue in endoscopic and other limited access procedures.

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ArthroCare Corporation Opus SmartStitch Suture Device Special Premarket Notification March 9, 2007 K090671 2/2

510(K) SUMMARY

Substantial Equivalence

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The Opus SmartStitch™ Suture Device with PerfectPasser Connector is substantially equivalent to the existing Opus® SmartStitch™ Suture Device with PerfectPasser Connector cleared by the Food & Drug Administration (K062244). The difference between the Opus® SmartStitch™ Suture Device and the predicate device does not raise any questions regarding the safety and effectiveness. Furthermore, the materials are well characterized. The device, as designed, is as safe and effective as the predicate device.

Summary and Reason for 510(k) Notification

The purpose of this 510(k) is to notify the Food and Drug Administration of a modification to the previously cleared device. The modification incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with PerfectPasser Connector. The primary difference includes the addition of a material.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.