The Unimax Veress Needle 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.

Device Description

The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

AI/ML Overview

The Unimax Veress Needle is not an AI/ML device, but rather a traditional medical device (a surgical instrument). Therefore, the provided document does not contain the information typically associated with AI/ML device evaluations, such as studies on algorithm performance, human-in-the-loop performance, ground truth establishment for training/test sets, or sample sizes related to AI model development.

The document describes the non-clinical testing performed to demonstrate the safety and effectiveness of the Unimax Veress Needle and its substantial equivalence to a predicate device.

Here's the information extracted from the document based on the provided categories, with "N/A" for criteria not applicable to a non-AI/ML device:

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

Acceptance Criteria (What was tested)	Reported Device Performance (Test Results)
Tip Pull Test	Meets pre-defined acceptance criteria
Switch Operation	Meets pre-defined acceptance criteria
Spring Obturator Operation	Meets pre-defined acceptance criteria
Needle Puncture Force Test	Meets pre-defined acceptance criteria
Cytotoxicity Test	Complies with ISO 10993-5
Intracutaneous Reactivity Test	Complies with ISO 10993-10
Maximization Sensitization Test	Complies with ISO 10993-10
EO Sterilization Validation Study	Complies with ISO 11135-1
Ethylene Oxide Sterilization Residuals Study	Complies with ISO 10993-7

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

The document lists "A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes (e.g., number of needles tested for each physical/mechanical test) or the exact provenance of the data (e.g., where the in vivo tests were conducted). It is indicated that the manufacturer is based in Taipei, Taiwan. The tests are non-clinical (preclinical), not clinical data, and appear to be prospective testing of the device itself rather than data collection from a population.

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)

N/A. This is a non-AI/ML device. Ground truth, in the context of AI, refers to expert-labeled data. For a physical medical device, performance is evaluated against engineering specifications and international standards, not against expert interpretation of data.

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

N/A. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI ground truth. For this device, performance is measured against technical specifications and standard compliance.

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

N/A. This is a non-AI/ML device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems.

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

N/A. This is a non-AI/ML device. "Standalone performance" refers to the performance of an AI algorithm without human involvement.

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

For this medical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (e.g., ISO 10993 series, ISO 11135-1) and demonstrating performance at least equivalent to the predicate device through physical and mechanical testing (e.g., Tip Pull Test, Switch Operation, Spring Obturator Operation, Needle Puncture Force Test). There is no "ground truth" in the AI sense for this type of product.

8. The sample size for the training set

N/A. This is a non-AI/ML device, so there is no training set for an algorithm.

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

N/A. This is a non-AI/ML device, so there is no training set for an algorithm.

Summary

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Unimax Medical Systems Inc. 510(k) Notification

AUG 1 9 2011

Unimax Veress Needle

510(k) Summary

5.1	Type of Submission:	Traditional
5.2	Preparation Date:	Apr 29, 2011
5.3	Revised Date:	Jul 27, 2011
5.4	Submitter:	Unimax Medical Systems Inc.
	Address:	8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien,Taipei, Taiwan
	Phone:	886-2-89191698
	Fax:	886-2-89191528
	Contact:	Sophia Chiu
	Establishment Registration Number:	3007791595

5.5 Identification of the Device:

Proprietary/Trade name:	Unimax Veress Needle
Common Name:	Veress Needle
Classification Name:	Insufflator, Laparoscopi-
Device Classification:	2
Regulation Number:	884.1730
Panel:	Obstetrics/Gynecology
Product Code:	HIF

5.6 Identification of the Predicate Device:

Predicate Device Name:	GeniCon Pneumo-Needle
Manufacturer:	GeniCon, L.C.
510(k) Number or Clearance Information:	K993625

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Unimax Veress Needle

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5.7 Intended Use and Indications for Use of the subject device.

5.8 Device Description

510(k) Notification

い

5.9 Non-clinical Testing

A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimax Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing, ISO 10993-5 Biological Evalustion of medical devices- Part 5: Test for in vitro cytotoxicity, ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, ISO 10993-10 Biological evaluation of medical devices- Part10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-12 Biological evaluation of medical devices- PArt12: Sample preparation and reference material, ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

· Cytotoxicity Test
· Intracutaneous Reactivity Test
· Maximization Sensitization Test
· EO Sterilization Validation Study Report
· Ethylene Oxide Sterilization Residuals Study Report

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Unimax Veress Needle

Unimax Medical Systems Inc. 510(k) Notification

The tests listed below have demonstrated that the subject device performs at least same performance as the predicate device.

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

All the test results demonstrate the performance of Unimax Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses.

The results of the non-clinical testing demonstrate that the Unimax Veress Needle is as safe and effective as the predicate devices.

5.10Substantial Equivalence Determination

The Unimax Veress Needle submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared GeniCon Pneumo-Needle which is the subject of K993625. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item	Proposed Device(Unimax Medical Systems Inc. VeressNeedle)	Predicate Device(GeniCon L.C. Pneumo-Needle)
Intended Use	The Unimax Veress Needle is intendedfor percutaneous insertion into theperitoneal cavity for the purpose ofinsufflation with carbon dioxide toestablish pneumoperitoneum prior to theplacement of trocars during laparoscopicprocedures.	The GeniCon Pneumo-Needle isintended for percutaneous insertion intothe peritoneal cavity for the purpose ofinsufflation with carbon dioxide toestablish pneumoperitoneum prior tothe placement of trocars duringlaparoscopic procedures.
	Consisted	Veress Needle	Veress Needle
	Instruments	Obturator	Obturator
	Models	xVN Series	Model 900-200
	Dimension	120mm, 150mm	120mm, 150mm

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Unimax Medical Systems Inc. 510(k) Notification

Unimax Veress Needle

Sterilization	EO Sterilized	EO Sterilized
Safetystandards	ISO 10993-1	ISO 10993-1
	ISO 10993-5	ISO 10993-5
	ISO 10993-7	ISO 10993-7
	ISO 10993-10	ISO 10993-10
	ISO 10993-12	ISO 10993-12
	ISO 11135-1	ISO 11135-1
Performancestandards	Not Applicable	Not Applicable
	Comparedperformancetesting	Tip Pull Test
Switch Operation		Switch Operation
Spring Obturator Operation		Spring Obturator Operation
Needle Puncture Force Test		Needle Puncture Force Test

5.11 Conclusion

After analyzing bench tests, safety testing data, it can be concluded that Unimax Veress Needle is as safe and effective as the predicate device.

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

Unimax Medical Systems Inc. % Mr. Michael Lee. President AcmeBiotechs Co., Ltd. No.45, Minsheng Rd. Danshui Town TAIPEI COUNTY 251 TAIWAN

Re: K111441

Trade/Device Name: Unimax Veress Needle Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated: May 20, 2011 Received: May 24, 2011

AUG 1 9 2011

Dear Mr. Lee:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K111441

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulda Gunn

(Division Sign-Off) Division of Reproductive, Gastro-Rep Urological Devices 510(k) Number

Page 1 of 1

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.