InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

The InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

Device Description

InnoClip™ Disposable Clip Applier consists of a molded handle and trigger, a 360° rotational knob, a cartridge housing shaft and a pair of jaws which is easy for surgeon to hold the operation field in the natural position. This device includes models DC5T1-BX and DC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Disposable Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Disposable Clip Applier enables the surgeon to apply a maximum number of 10 clips for DC5T1-BX or 16 clips for DC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The pre-loaded clips in the shaft are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

InnoClip™ Clip Applier has two parts, Reusable Handle and a Disposable Clip Cartridge. The Reusable Handle consists of a molded handle, trigger, openable cover and a 360° rotational knob. The Disposable Clip Cartridge consists of a cartridge housing shaft and a pair of jaws which provide secured of the clip to the targeted vessel. The Disposable Clip Cartridge and the Reusable Handle can be easily assembled together by inserting the Disposable Clip Cartridge through a slot located in the Reusable Handle. This device includes models RC5T1-BX and RC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Clip Applier enables the surgeon to apply a maximum number of 10 clips for RC5T1-BX or 16 clips for RC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The reusable handle design also reduces the surgical cost and waste. The pre-loaded clips in the Disposable Clip Cartridge are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

AI/ML Overview

The provided text is a 510(k) Summary for the InnoClip™ Disposable Clip Applier and InnoClip™ Clip Applier devices. It describes the device, its intended use, and provides a summary of performance testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it describes performance testing and generally states that the devices "met all acceptance criteria" or "have similar device performance compared to the predicate."

Here's a summary derived from the text:

Test/Performance Metric	Acceptance Criteria (Implied/General)	Reported Device Performance
In-vitro Tests
Clipped Pull Out Force Test (Silicone tube)	Similar performance to the predicate device	Both proposed devices have similar device performance compared to the predicate device.
Air Leakage Test (Silicone tube)	Similar performance to the predicate device	Both proposed devices have similar device performance compared to the predicate device.
Clip Scissoring (Silicone tube)	Met all acceptance criteria and performed as well as the predicate device	The proposed devices met all acceptance criteria and performed as well as the predicate device.
In-vivo Tests
Ligation in Swine Model	Ability to ligate target vessels and tubular tissue as intended	The proposed devices and the predicate device can ligate the target vessels and tubular tissue as its intended use.
Reusable Handle Durability	Maintain performance functions for up to 300 uses after reprocessing	The reusable handle has been validated to maintain performance functions for up to 300 times following reprocessing.
Biocompatibility	Meet ISO 10993-1 and FDA Guidance	All biocompatibility met the acceptance criteria.

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

Sample Size: The document does not specify the exact sample sizes (number of devices, number of clips tested, number of animals) used for any of the performance tests. It mentions performing "in-vitro tests" and "in-vivo ligation tests" but lacks quantitative details on sample size.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It is a submission by "Taiwan Surgical Corporation" but this does not confirm the location of the studies.

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 provided in the document. The tests described (e.g., pull-out force, air leakage, in-vivo ligation) are largely objective performance tests of the device itself rather than assessments requiring human expert interpretation for ground truth.

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

This information is not applicable and not provided in the context of this device. The tests are focused on mechanical and functional performance, not diagnostic interpretations requiring 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

This information is not applicable and not provided in the document. This device is a surgical clip applier, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not involve an algorithm.

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

The concept of "ground truth" as typically defined for AI or diagnostic devices (e.g., expert consensus, pathology, outcomes) is not directly applicable to the performance testing described for this mechanical surgical device. The "ground truth" for these tests would be the objective measurement results (e.g., actual pull-out force, actual air leakage rate, observable successful ligation in a animal model) as measured by laboratory equipment and veterinary observation, compared against pre-defined performance acceptance thresholds or predicate device performance.

8. The sample size for the training set

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set as would an AI/machine learning model.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set.

Summary

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January 4, 2022

Taiwan Surgical Corporation Ken Chen Project Director 3F., No.12, Sec.2, ShengYi Rd. Zhubei City, Hsinchu County 30261 Taiwan

Re: K202994

Trade/Device Name: InnoClip Disposable Clip Applier, InnoClip Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP, GDO Dated: July 6, 2021 Received: July 7, 2021

Dear Ken Chen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Deborah Fellhauer RN, BSN Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202994

Device Name InnoClip™ Disposable Clip Applier InnoClip™ Clip Applier

Indications for Use (Describe)

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

The Assigned 510(k) Number: _ K202994

This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92

1 SUBMITTER:

Submitter:	TAIWAN SURGICAL CORPORATION
Mailing Address:	3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County 302-
	Taiwan
Phone Number:	+886-3-6588129
Fax Number:	+886-3-6588355
Date Prepared:	December 8, 2021
Contact Person:	Ken Chen
Email:	ra@twsc.com.tw
Phone Number:	+886-3-6588129 ext. 519
Fax Number:	+886-3-3588355

2 DEVICE

Trade Name:	1. InnoClip™ Disposable Clip Applier
	2. InnoClip™ Clip Applier
Common Name:	Clip applier and implantable clip
Classification Panel:	79 General and Plastic Surgery
Regulation Number:	878.4300
Classification Product Code:	FZP
Device Class:	II
Additional Regulation Number:	878.4800
Additional Product Code:	GDO
Additional Device Class:	I

3 PREDICATE DEVICE

ENDO CLIP™ III 5mm Clip Applier (K121194)

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DEVICE DESCRIPTION 4

InnoClip™ Disposable Clip Applier

InnoClip™ Clip Applier

INTENDED USE 5

InnoClip™ Clip Applier is indicated for patients undergoing surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

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MATERIAL 6

All patient contacting materials, including those with indirect patient contact, have been evaluated according to ISO 10993-1 and the FDA's Guidance Use of International Standard ISO 10993-1, dated June 16, 2016. All biocompatibility met the acceptance criteria.

TECHNOLOGICAL CHARACTERISTICS 7

A comparison of the technological characteristics of the proposed InnoClip™ Disposable Clip Applier InnoClip™ Clip Applier, and the predicate has been performed. The results of this comparison demonstrate that the InnoClip™ Disposable Clip Applier and InnoClip™ Clip Applier have similar technological characteristics compared to the marketed predicate device.

PERFORMANCE 8

In-vitro tests conducted on a silicone tube substrate including clipped pull out force test and air leakage test were performed on InnoClip™ Disposable Clip Applier and InnoClin™ Clip Applier to compared with the predicate device. The test results showed that both proposed devices have similar device performance compared to the predicate device.

In-vivo ligation tests were performed in a swine model using the InnoClip™ Disposable Clip Applier. InnoClip™ Clip Applier and the predicate device, and the results demonstrated that the proposed devices and the predicate device can ligate the target vessels and tubular tissue as its intended use.

Comparison testing was conducted on a silicone tube substrate with the InnoClip™ Disposable Clip Applier, InnoClip TM Clip Applier and predicate device to assess clip scissoring. The proposed devices met all acceptance criteria and performed as well as the predicate device.

The reusable handle of InnoClip™ Clip Applier has been validated to maintain performance functions for up to 300 times following the reprocessing methods described in the instructions for use.

9 CONCLUSIONS

Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the InnoClip™ Disposable Clip Applier and InnoClip™ Clip Applier are substantially equivalent to the predicate device Endo Clip™ III.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.