The Disposable Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars opic procedures.

Device Description

The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures. The device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths. There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Disposable Veress Needles." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the requested information about acceptance criteria and a study proving device performance (especially points relevant to AI/ML such as test set size, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment) cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

The document primarily discusses non-clinical testing for physical properties, biocompatibility, sterilization, and shelf-life of a physical medical instrument (a Veress needle), not an AI/ML diagnostic or predictive tool.

Here's a breakdown of what can be extracted, and where the requested information is absent:

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

Acceptance Criteria: The document states, "The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria." However, the specific numerical or qualitative acceptance criteria (e.g., "puncture force must be within X to Y Newtons") are not explicitly detailed in the provided text. Instead, categories of tests are listed.
Reported Device Performance: The document only states that the device "performs as well as the predicate device" after these tests. No specific performance results (e.g., actual measured tip pull force, switch operation timing, etc.) are provided.

Acceptance Criteria Category	Reported Device Performance Statement
Tip Pull Test	Demonstrated performance as well as the predicate device
Switch Operation	Demonstrated performance as well as the predicate device
Spring Obturator Operation	Demonstrated performance as well as the predicate device
Needle Puncture Force Test	Demonstrated performance as well as the predicate device
Biocompatibility (Cytotoxicity)	Evaluated in accordance with ISO 10993-5:2009
Biocompatibility (Skin Sensitization)	Evaluated in accordance with ISO 10993-10:2021
Biocompatibility (Intracutaneous Reactivity)	Evaluated in accordance with ISO 10993-23:2021
Biocompatibility (Acute Systemic Toxicity)	Evaluated in accordance with ISO 10993-11:2017
Biocompatibility (Pyrogenicity)	Evaluated in accordance with ISO 10993-11:2017
Sterilization Validation	Validated in accordance with ISO 11135:2014
Sterilant Residuals	Evaluated in accordance with ISO 10993-7:2019
Simulated Distribution Testing	Performed in accordance with ASTM D4169
Packaging Integrity (ASTM F1886/F1886M-16)	Performed in accordance with ASTM F1886/F1886M-16
Packaging Integrity (ASTM F88/F88M-15)	Performed in accordance with ASTM F88/F88M-15
Packaging Integrity (ASTM F1929-15)	Performed in accordance with ASTM F1929-15
Shelf-life	3 years, determined after aging per ASTM F1980-21

Regarding points 2-9, which are highly relevant for AI/ML device evaluations, the information is not present in this document because it describes a physical medical device, not an AI/ML algorithm.

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

Not applicable / Not provided. This document does not describe a study involving data sets for an AI/ML algorithm. The "test set" here refers to physical units of the device subjected to non-clinical tests. The number of samples for each physical test (e.g., how many needles were tested for tip pull) is not specified.

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)

Not applicable / Not provided. Ground truth definition by experts is not relevant for the non-clinical physical and biological tests described for a Veress needle.

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

Not applicable / Not provided. Adjudication methods are relevant for expert consensus on AI/ML ground truth, not for physical device testing.

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

Not applicable / Not provided. This is explicitly for AI-assisted diagnostic devices and does not apply to a standalone physical surgical instrument like a Veress needle.

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

Not applicable / Not provided. This is for AI algorithms, not a physical medical device.

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

Not applicable / Not provided. The "ground truth" for the physical device tests would be objective measurements against an engineering standard or predicate device performance, not expert consensus on medical findings.

8. The sample size for the training set

Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set.

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

Not applicable / Not provided. There is no AI/ML algorithm, and thus no training set or ground truth establishment method for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

December 14, 2023

Hangzhou Kangji Medical Instrument Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2. Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China

Re: K232401

Trade/Device Name: Disposable Veress Needles Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: November 13, 2023 Received: November 16, 2023

Dear Esther Zhang:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about mediation-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,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K232401

Device Name Disposable Veress Needles

Indications for Use (Describe)

Disposable Veress Needles

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 Disposable Veress Needles K232401

1. Submitter Information

Hangzhou Kangji Medical Instrument Co., Ltd. No. 1668 Chunjiang East Road Economic Development Zone, Tonglu, Hangzhou, 311501 China Contact person: Martin Sun Manager of Regulatory Affairs Phone: +86-0571-69901712 Fax: +86-0571-69901712 Email: martin.sun@kangji.com

2. Submission Correspondent

Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R. China Contact person: Esther Zhang Email: Esther.zhang@llins-tech.com

3. Date Prepared

December 13, 2023

4. Device Identification

Trade Name of Device:	Disposable Veress Needles
Common Name:	Veress Needle
Model:	I, II
Regulation Name:	Laparoscopic Insufflator
Regulation Number:	884.1730
Product Code:	HIF (Insufflator, Laparoscopic)
Class:	Class II

5. Legally Marketed Predicate Device

Trade Name:	Unimicro Veress Needle
Common Name:	Veress Needle
Manufacturer:	Unimicro Medical Systems (ShenZhen) Co., Ltd.
Regulation Name:	Laparoscopic Insufflator;
Regulation Number:	884.1730
Product Code:	HIF, FHO

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510(k) number: K150068 Class: 11

The predicate device has not been subject to a design-related recall.

6. Device Description

There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.

7. Indication for Use

8. Comparison of technological characteristics with the predicate device

	Disposable Veress Needles	Unimicro Veress NeedleK150068	Discussion
Manufacturer	Hangzhou Kangji MedicalInstrument Co., Ltd.	Unimicro Medical Systems(ShenZhen) Co., Ltd.
Product Code	HIF	HIF, FHO	Same
Regulation Number	884.1730	884.1730, 876.1500	Same
Class	Class II	Class II	Same
Indications for Use	The Disposable VeressNeedles are intended forpercutaneous insertion intothe peritoneal cavity for thepurpose of insufflation withcarbon dioxide to establishpneumoperitoneum prior tothe placement of trocarsduring laparoscopicprocedures.	The Unimicro Veress Needle isintended for percutaneousinsertion into the peritonealcavity for the purpose ofinsufflation with carbondioxide to establishpneumoperitoneum prior tothe placement of trocs duringlaparoscopic procedures	Same
Conditions of Use	Rx Only; Single Use Only	Rx Only; Single Use Only	Same
Sterilization	Ethylene Oxide	Ethylene Oxide	Same
Models	I, II	MDN 11200, MND 11500	Different: The subjectdevice is available indifferent models thanthe predicate device

Table 1. Comparison of Characteristics

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			based on length and,for Model II of thesubject device, asilicone sleeve on thehandle. This differencedoes not raise differentquestions of safety andeffectiveness (S&E).
Lengths	110±4mm, 120±4mm,130±4mm, 140±4mm,150±4mm	120mm, 150mm	Different: The subjectdevice is available inmore lengths than thepredicate. Thisdifference does notraise differentquestions of S&E.
Components	Needle, Inner core, Handle,and Valve	Veress Needle, Obturator	Same
Needle Material	Stainless Steel	Stainless Steel	Same
Handle Material	PC	ABS	Different: The subjectdevice handle materialis different than thepredicate device. Thisdoes not raise differentquestions of S&E.
Principles ofOperation	Connect the device to theinsuffators with tubing,insufflate with carbon dioxideto establishpneumoperitoneum.	Connect the device to theinsuffators with tubing,insufflate with carbon dioxideto establishpneumoperitoneum.	Same

As shown in the table above, there are differences in the lengths and materials of the subject and predicate devices. However, as stated in the table, the differences in technological features do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Testing

The tests listed below have demonstrated that the subject device performs as well as the predicate device based on the acceptance criteria:

-Tip Pull Test
-Switch Operation
-Spring Obturator Operation
-Needle Puncture Force Test

Biocompatibility testing

Biocompatibility of the Disposable Veress Needles was evaluated in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Testing included:

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Cytotoxicity	ISO 10993-5:2009
Skin Sensitization	ISO 10993-10:2021
Intracutaneous Reactivity	ISO 10993-23:2021
Acute Systemic Toxicity	ISO 10993-11:2017
Pyrogenicity	ISO 10993-11:2017

Sterilization Validation and Shelf-life Testing

Sterilization was validated in accordance with ISO 11135:2014. Sterilant residuals were evaluated in accordance with ISO 10993-7:2019.

Combined simulated shipping distribution, stability, and packaging integrity testing was performed in accordance with the 2016 FDA guidance document, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff. Testing included:

Simulated distribution testing ASTM D4169 Packaging integrity testing ASTM F1886/F1886M-16 ASTM F88/F88M-15 ASTM F1929-15

The 3 year shelf-life of the device was determined based on stability of package integrity and performance testing after aging per ASTM F1980-21.

10. Statement of Substantial Equivalence

The Disposable Veress Needles are substantially equivalent to the predicate device (Unimicro Veress Needle). The technological differences between the predicate and subject device do not raise different questions of safety or effectiveness. The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device.

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.