The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

Device Description

The PROXISURE™ Suturing System is composed of a reusable PROXISURE™ Suturing Device and single-use, sterile Suture Cartridges that are used for placement of interrupted or running stitches in soft tissue. The Suturing Device has a stationary shaft that has an articulating and rotating end effector. The device is reusable and must be cleaned and sterilized by the end user per the cleaning, disinfection, and sterilization instructions provided in the Instructions for Use before and between uses. A Suture Cartridge is loaded at the distal tip of the end effector which contains the needle and suture for use during the surgical procedures.

The PROXISURE ™ Suture Cartridges are designed for use with the PROXISURE™ Suturing Device and are available with two types of sutures in three sizes each. The suture material is commercially available Coated VICRYL™ and ETHIBOND EXCEL™ sutures. ETHIBOND™ Suture is dyed green with D&C Green #6 (Color Index No. 61565) to enhance visibility in the surgical field. ETHIBOND Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile poly(ethylene terephthalate) Suture and the United States Pharmacopoeia (USP) for Non-Absorbable Surgical Sutures. Coated VICRYL™ Sutures that come with the Suture Cartridge are dyed by adding D+C violet #2 (Color Index number: 60725) during polymerization. Coated VICRYL™ Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) for Sterile Synthetic Absorbable Braided Sutures, except for an occasional slight oversize in the gauges for the suture cartridge. The PROXISURE™ Suturing Device and the Suture Cartridges are packaged separately and will be available for assembly prior to use at the surgical site.

AI/ML Overview

This document is a 510(k) Pre-market Notification from the FDA for the PROXISURE Suturing Device and its associated Suture Cartridges. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable or cannot be extracted from this type of regulatory document.

However, I can provide information based on the performance data presented in the summary, which states that bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Needle passing reliability (e.g., successful needle passing rate)	Bench testing demonstrated performance meeting substantial equivalence.
Needle passing and tissue sticking (e.g., absence of sticking)	Bench testing demonstrated performance meeting substantial equivalence.
Knot strength (e.g., strength comparable to predicate)	Bench testing demonstrated performance meeting substantial equivalence.
Needle pull-off strength (e.g., strength comparable to predicate)	Bench testing demonstrated performance meeting substantial equivalence.
Suture manipulation needle release (e.g., proper release mechanism)	Bench testing demonstrated performance meeting substantial equivalence.
Cartridge cage pullback (e.g., proper function of pullback)	Bench testing demonstrated performance meeting substantial equivalence.
Needle release force (e.g., force within acceptable range)	Bench testing demonstrated performance meeting substantial equivalence.
End effector features testing (e.g., proper articulation/rotation)	Bench testing demonstrated performance meeting substantial equivalence.

Explanation: The document does not provide specific quantitative acceptance criteria or detailed quantitative results. Instead, it states that
Bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.
This implies that the acceptance criteria were based on demonstrating comparable performance to the predicate device in these specific areas.

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

Sample Size for Test Set: Not specified. The document only mentions "bench testing."
Data Provenance: Not specified, but generally, bench testing is conducted in a laboratory setting, not typically tied to a specific country of origin in the same way clinical data would be. It is not retrospective or prospective clinical 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 question is not applicable to this document. The "ground truth" concept is more relevant for diagnostic or AI devices where a definitive expert-determined label or outcome is needed. For mechanical device bench testing, "ground truth" is typically defined by engineering specifications and objective measurements, not subjective expert assessment of an outcome in the same way.

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

This question is not applicable to this document. Adjudication methods are used in studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Bench testing of a mechanical device does not typically involve such adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant to a mechanical suturing device.

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

This question is not applicable to this document. This refers to the standalone performance of an AI algorithm. The PROXISURE Suturing Device is a mechanical device, not an AI or algorithm. The "bench testing" described is for the mechanical function of the device, which is its standalone performance.

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

Type of Ground Truth: For the bench testing described, the "ground truth" would be established by engineering specifications, material science properties, and objective physical measurements against predefined performance standards or in comparison to the predicate device's measured performance. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not applicable. This device is a mechanical suturing device, not an AI or machine learning model that requires a "training set."

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

Not applicable. As above, there is no "training set" for this type of device.

Summary

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

June 3, 2016

Ethicon Endo-Surgery, Inc. Ms. Rubina Dosani, M.S. Sr. Regulatory Affairs Project Lead 4545 Creek Road Cincinnati, OH 45242

Re: K153611

Trade/Device Name: Coated VICRYL (Polyglactin 910)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM, GAT, OCW Dated: May 3, 2016 Received: May 5, 2016

Dear Ms. Dosani:

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

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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 and 809); 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153611

Device Name PROXISURE™ Suturing Device ETHIBOND™ Suture Cartridge Coated VICRYL™ Suture Cartridge

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information:	Ethicon, LLC
	475 C Street
	Guaynabo, PR 00969

Application Correspondent

Rubina Dosani Sr. Regulatory Affairs Project Lead Ethicon Endo-Surgery, Inc. Telephone: Fax: Email: rdosani@its.jnj.com

Date Prepared December 16, 2015

PROXISURE™ Suturing System which includes the following components: PROXISURE™ Suturing Device, Coated VICRYLTM Suture Cartridge, ETHIBOND™ Suture Cartridge.

Device Trade Name:	PROXISURE™ Suturing Device
Device Common Name:	Endoscopic Suturing Device
Classification Regulation:	21 CFR 876.1500
Device Class:	II
Panel:	General & Plastic Surgery
Product Code:	OCW
Device Trade Name:	Coated VICRYL™ Suture Cartridge
Device Common Name:	Suture, Absorbable, Synthetic, Polyglycolic Acid
Classification Regulation:	21 CFR 878.4493
Device Class:	II
Panel:	General & Plastic Surgery
Product Code:	GAM
Device Trade Name:	ETHIBOND™ Suture Cartridge
Device Common Name:	Suture, Non-Absorbable, Synthetic, Polyethylene
Classification Regulation:	21 CFR 878.5000
Device Class:	II
Panel:	General & Plastic Surgery
Product Code:	GAT
Predicate Devices:	Modified Endo Stitch™ (K082659)
	Coated VICRYL™ (Polyglactin 910) Sterile SyntheticAbsorbable Suture (K022269)
	ETHIBOND EXCEL™ Polybutlylate Coated Polyester SterileSynthetic Non-Absorbable Suture (K946173)

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K153611, Page 2 of 3

Device Description

Indications for Use for the components of the PROXISURE™ Suturing System

The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

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Substantial Equivalence Summary

The subject and predicate devices have the same intended use and primary surgical use - suturing in minimally invasive surgeries with applications for the placement of interrupted or running stitches in soft tissue. Both subject and predicate devices are mechanical devices where no energy passes through to the patient, are not battery operated and do not use software.

Technological Characteristics

The suturing device is composed of a reusable handle and shaft with a rotating and articulating distal end effector. The working length of the suturing device is 40 cm with a 12mm diameter which will fit through a 12mm trocar. A single-use, sterile Suture Cartridge is loaded at the distal tip of the end effector containing the needle and suture for use during surgical procedures.

Performance Data

Bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended. Bench testing included needle passing reliability testing, needle passing and tissue sticking testing, knot strength testing, needle pull off strength, suture manipulation needle release, cartridge cage pullback, needle release force and end effector features testing.

The conclusions of the testing criteria demonstrate the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.

This submission does not include data from Clinical Studies.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.