The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.

Device Description

The Clip Applier consists of a handle piece and implantable titanium clips. The Clip Applier handle piece consists of a molded handle and trigger, a 360 degrees rotational knob, a cartridge housing shaft and a pair of jaws which provide secured placement of the clip to the desired vessel. The design enables the surgeon to apply several clips during a laparoscopic procedure without the need for withdrawing and reinserting the Clip Applier each time a clip is put in place and closed. The Clip Applier is designed to be used with a black loaded, sterile cartridge supplied in a sterile pouch. The single use disposable clip cartridge sits inside the shaft of the Clip Applier handle piece. While fully squeezing the hand piece trigger, the cartridge is inserted into the shaft through a slot located in the instrument rear.

AI/ML Overview

This device is a surgical CLIP PLUS Disposable Clip Applier, ML and L models, used in endoscopic procedures for ligating vessels and tubular structures. The document is a 510(k) premarket notification letter from the FDA, approving the device for marketing.

Here’s an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents a comparison of the subject device's performance against a predicate device. The performance data is presented as a comparison, implying that the subject device's results needed to be comparable or equivalent to the predicate.

Performance Metric	Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (CLIP PLUS)	Predicate Device Performance (MICROLINE PENTAX, K013695)
Clip Formation	All clips properly formed	All clips properly formed	"Pass" (Implied: properly formed)
Clip Gap Measurement	No significant difference from predicate	$0.215 \pm 0.024$ mm	$0.223 \pm 0.005$ mm
Perpendicular Clip Pull	Similar to predicate (not easily dislodged)	$315 \pm 11$ g	$305 \pm 11$ g
Parallel Clip Pull	Similar to predicate (not easily sliding)	$627 \pm 41$ g	$622 \pm 52$ g
Airtight Capability	No air leakage (15 to 30 PSI)	No air leakage (silicone tube 3.0 & 2.0 mm O.D. at 15-30 PSI)	"Pass" (Implied: no air leakage)
Biocompatibility	Meet ISO 10993 requirements	Passed ISO 10993 tests	(Standard materials, thoroughly tested in the past)
Sterilization (Gamma)	Meet ISO 11137-2:2012 VD max25 method for SAL of 10^-6	Successful, met ISO 11137-2:2012 VD max25 for SAL of 10^-6	(Not explicitly stated for predicate in this context)

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

Sample Size for Test Set: The document does not specify the exact sample size for the performance tests (clip formation, clip gap, pull tests, airtight capability). It refers to "the clips" and "tested clips" without providing numbers.
Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is "TAIWAN SURGICAL CORPORATION" located in Hsinchu County, Taiwan, suggesting the testing likely occurred in Taiwan. The study appears to be retrospective in the sense that it's a bench test comparison against an existing predicate, not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the document describes a medical device (clip applier) and its mechanical and material performance, not an AI/algorithm-based diagnostic device requiring expert ground truth for interpretation. The "ground truth" for these tests is based on objective physical measurements and established international standards (e.g., ISO 10993, ISO 11137-2).

4. Adjudication Method for the Test Set

Not applicable for this type of device and performance testing. Adjudication methods like 2+1 or 3+1 are typically used for assessing disagreements among human readers or experts in diagnostic studies, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not applicable to a surgical clip applier.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (a clip applier), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation includes:

Objective Measurements: For clip gap, perpendicular clip pull, and parallel clip pull, the "ground truth" is the measured physical property of the clips and their strength.
Pass/Fail Criteria based on expectations/standards: For clip formation and airtight capability, the "ground truth" is a binary outcome (Pass/Fail) based on whether the clips functioned as intended and prevented air leakage.
International Standards: For biocompatibility (ISO 10993) and sterilization (ISO 11137-2), the "ground truth" is compliance with these recognized international standards.
Predicate Device Performance: The primary comparison for "ground truth" or acceptable performance is explicitly stated as the performance of the legally marketed predicate device (MICROLINE PENTAX, K013695).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design and performance are based on engineering principles, material science, and mechanical testing.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set is not relevant.

Summary

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

November 6, 2015

Taiwan Surgical Corporation Ms. Hsiu-Ping Huang Regulatory Specialist 3F., No. 12, Sec. 2. Sheng Yi Rd. Zhubei City, Hsinchu County 30261 Taiwan

Re: K150259

Trade/Device Name: CLIP PLUS Disposable Clip Applier, ML CLIP PLUS Disposable Clip Applier, L Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP. GDO Dated: January 30, 2015 Received: October 5, 2015

Dear Ms. Huang:

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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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.

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) K150259

Device Name

CLIP PLUS Disposable Clip Applier, ML CLIP PLUS Disposable Clip Applier, L

Indications for Use (Describe)

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

The Assigned 510(K) Number: K150259 Date Prepared: 11/06/2015

I. SUBMITTER:

Submitter:

TAIWAN SURGICAL CORPORATION

Address: 3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County 302, Taiwan

Phone Number: +886-3-6588129

Fax Number: +886-3-6588355

Contact Person: Ging-Wen Lu

Email: lulu@taiwansurgical.com.tw

Phone Number: +886-3-6588129 ext. 260

Fax Number: +886-3-6588355

II. DEVICE

Trade Name:

CLIP PLUS™ Disposable Clip Applier, ML .
CLIP PLUS™ Disposable Clip Applier, L .

Common Name and Classification:

Table 1. Common Name and Classification

No.	Common Name	Product Code	Classification	RegulationSection	Panel
1	Applier, surgical, clipand implantable clip	GDOFZP	I, exemptII	878.4800878.4300	General &PlasticSurgery

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III. PREDICATE DEVICE

Predicate Device 1: MICROLINE PENTAX, INC., K013695

Subject Device	Predicate Device
	Predicate Device	Manufacturer	510(k) Number
CLIP PLUSTMDisposable ClipApplier	Reusable laparoscopic clipapplier with implantabletitanium clip	MICROLINEPENTAX, INC.	K013695

Table 2. Predicate Device Identification

IV. DEVICE DESCRIPTION

v. INDICATIONS FOR USE

VI. PRODUCT SPECIFICATION

The shaft of the Clip Applier handle piece is sized to fit through 10mm cannula ports and the overall length of the shaft is 300mm for TDC-10-ML while the overall length of the shaft is 350mm for TDC-10-L. For TDC-10-ML, the clip length is 9mm long when closed and the clip

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depth is 7.5mm; for TDC-10-L, the clip length is 10.5mm long when closed and the clip depth is 9.5mm.

VII. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PRIDICATE DEVICE

Features		Candidate Device	Predicate Device
1	HandPiece	Long tubediameter	10mm	10mm
2	Long tube length		290mm/340mm	300mm/350mm
3	Staple quantity		20	20
4	Counter		N	Y
5	Instructions		Y	Y
6	Staple fallen outpreventionmechanism		N	Y
7	Surgical field		15°	15°
8	TitaniumClip	Staple wire	0.9x0.6mm	0.9x0.6mm
9	Staple wide		4.3mm	4.3mm
10	Staple depth		6.9mm/9.5mm	6.9mm/9.5mm
11	Pinch flat length		9mm/10.5mm	9mm/10.5mm
12	Function	Clip Formation	Pass	Pass
	Clip Gapmeasurement		$0.215\pm0.024$ mm	$0.223\pm0.005$ mm
	PerpendicularClip Pull		$315\pm11$ g	$305\pm11$ g
	Parallel Clip Pull		$627\pm41$ g	$622\pm52$ g
	AirtightCapability		Pass	Pass
13	Regulatory Classification		class II	class I/class II

		878.4800	878.4800
		878.4300	878.4300
	Intended use	Use of these products is indicated in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels with Titanium clips.	The Microline reusable laparoscopic clip applier with implantable titanium surgical clip is intended for use to occlude vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures.
15	Package	Blister with Tyvek lid	Blister with Tyvek lid

Table 3. Specification Comparison Table

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PERFORMANCE DATA VIII.

Biocompatibility :
Because the stainless steel and titanium are standard materials for current clip applier on the market, they have been thoroughly tested in the past for biocompatibility. The product has passed the biocompatibility tests by following ISO 10993. The contact time for the device is permanent (≥ 30 days) with the body.
Performance Testing :
The Bench report of Disposable Clip Applier indicates the following results. In clip formation test, the clips were all properly formed by the clip applier. In clip gap measurement, there is no significant difference between Taiwan Surgical Corporation (TWSC) and MICROLINE applier. The perpendicular clip pull test shows that the TWSC result is similar with the MICROLINE result suggested that the TWSC clips is not easily dislodged from the blood vessel. The parallel clip pull test shows that the TWSC result is similar with the MICROLINE result suggested that the TWSC clips is not easily sliding over the blood vessel. The airtight capability test result reveals that no tested clips applied to silicone tube (3.0 and 2.0 mm O.D.) allowed for any air

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leakage of both clip Appliers through the air pressure from 15 to 30 PSI.

Sterilization Verification Testing:
The sterilization validation of gamma irradiation for disposable clip applier was successful and had met the requirements of ISO 11137-2:2012 VD max25 method on substantiation of 25kGy as a sterilization dose. This study therefore supports the multiple batch products to be irradiated at the sterilization dose kGy for a SAL of 10 °.

IX. CONCULSIONS

The CLIP PLUS™ Disposable Clip Applier with implantable titanium clip has the same intended use and same basic technology as the predicate device, thus is able to achieve same effectiveness and safety as the predicate device.

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.