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

AI/ML Overview

The provided document is a 510(k) summary for the Unimicro Veress Needle. It outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific performance metrics against acceptance criteria. Therefore, directly addressing all points of your request for a study proving device acceptance criteria is not fully possible from this document, as it focuses on non-clinical performance and comparison.

However, I can extract the relevant information regarding acceptance criteria and testing where available.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Unimicro Veress Needle underwent non-clinical testing to demonstrate its safety and effectiveness, and to establish substantial equivalence to its predicate device (Unimax Veress Needle, K111441). The acceptance criteria for these tests were "pre-defined," and the device "met the requirements of the pre-defined acceptance criteria." The specific numerical or qualitative values of these pre-defined acceptance criteria are not explicitly stated in the provided text. The study involved a series of in vitro and in vivo preclinical physical, mechanical, and biocompatibility tests.

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

Test	Acceptance Criteria (as implied)	Reported Device Performance
Biocompatibility Tests	Adherence to ISO standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-12:2012	Met the requirements of the pre-defined acceptance criteria (implied compliance with ISO standards for biocompatibility)
Cytotoxicity Test	(Not explicitly stated, but implied to be non-cytotoxic)	Met the requirements of the pre-defined acceptance criteria
Skin Irritation Test	(Not explicitly stated, but implied to be non-irritating)	Met the requirements of the pre-defined acceptance criteria
Skin Sensitization Test (Guinea Pig maximization test)	(Not explicitly stated, but implied to be non-sensitizing)	Met the requirements of the pre-defined acceptance criteria
EO Sterilization Validation	(Not explicitly stated, but implied to achieve sterility assurance level)	Met the requirements of the pre-defined acceptance criteria
Ethylene Oxide Sterilization Residuals Test	(Not explicitly stated, but implied to be within safe limits)	Met the requirements of the pre-defined acceptance criteria
Physical/Mechanical Tests	Performance "as well as the predicate device" and meeting "pre-defined acceptance criteria"	Performed as well as the predicate device and met pre-defined acceptance criteria
Tip Pull Test	(Not explicitly stated, but implied to withstand a certain force)	Met the requirements of the pre-defined acceptance criteria
Switch Operation	(Not explicitly stated, but implied to operate smoothly and reliably)	Met the requirements of the pre-defined acceptance criteria
Spring Obturator Operation	(Not explicitly stated, but implied to operate effectively)	Met the requirements of the pre-defined acceptance criteria
Needle Puncture Force Test	(Not explicitly stated, but implied to be within acceptable force ranges for puncture)	Met the requirements of the pre-defined 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)

The document does not specify sample sizes for any of the non-clinical tests. It also does not discuss data provenance in terms of country of origin or whether the study was retrospective or prospective, as these are typically considerations for clinical studies and not explicitly for non-clinical lab testing of a medical device's physical properties.

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 applicable and not provided in the document. The tests described are non-clinical, mechanical, and biocompatibility tests conducted in a laboratory setting. Ground truth in this context would typically refer to established scientific standards (e.g., ISO standards) and objective measurements rather than expert consensus on interpretations of data (as would be the case for medical imaging or diagnostic devices).

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

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment. The tests performed are objective laboratory tests.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices often involving human interpretation and AI assistance, neither of which are discussed for this device. The document explicitly states "non-clinical testing" and compares the device to a predicate based on physical, mechanical, and biocompatibility properties.

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

This information is not applicable and not provided. The device is a physical Veress Needle, not an algorithm or software. Therefore, the concept of standalone algorithm performance is not relevant.

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

The "ground truth" for the non-clinical tests described would be based on objective measurements against established engineering, material, and biological safety standards (e.g., force values, operational efficiency, compliance with ISO 10993 standards for biocompatibility). It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, which are not involved with this physical medical device.

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

This information is not applicable and not provided as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

July 31, 2015

Unimicro Medical Systems (ShenZhen) Co., Ltd. Weizhong Chen Vice General Manager 2/f, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District ShenZhen City, Guangdong 518106 China

Re: K150068 Trade/Device Name: Unimicro Veress Needle Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated: June 17, 2015 Received: June 23, 2015

Dear Weizhong 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. 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

Public Health Service

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

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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.

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director 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) K150068

Device Name

Unimicro Veress Needle, models : MND 11200, MND 11500

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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1 | Unimicro Medical Systems (ShenZhen) Co., Ltd. BIRTHHE 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with 21 CFR §807.92.

Type of submission: Traditional

The assigned 510(K) number is:_ K150068

Date of Preparation: JULY 1, 2015

1. Submitter information:

Manufacturer Name: Unimicro Medical Systems (ShenZhen) Co.,Ltd. Address: 2/F, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District, ShenZhen City,Guangdong Province, China Tel: 0086-755-27111581 Fax: 0086-755-27111580 Establishment Registration Number: 3010806467

2. Contact person:

Mr. Weizhong Chen (Vice General Manager)

E-mail: info@unimicromed.com

3. Identification of the Device :

Trade Name: Unimicro Veress Needle

Common Name: Veress Needle

Model: MND 11200, MND 11500

ClassificationName	ProductCode	RegulationNumber	RegulatoryClass	Review Panel
Insufflator,Laparoscopic	HIF	21CFR884.1730	II	Obstetrics/Gynecology
PneumoperitoneumNeedle	FHO	21CFR876.1500	II	Gastroenterology/Urology

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O Unimicro Medical Systems (ShenZhen) Co., Ltd.

4. Identification of the Predicative Device

DeviceName	CommonName	Manufacturer	Classificationand ProductCode	Classificationregulation	510(k)number
UnimaxVeressNeedle	VeressNeedle	UnimaxMedicalSystems Inc.	Class II,HIF	21CFR884.1730	K111441
			Class II,FHO	21CFR876.1500

Table 1: Predicative Device Information

5. Indications for Use

6. Device Description

7. 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 Unimicro Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-12:2012 and ISO 11135-1:2007.

Cytotoxicity Test .
Skin irritation Test •
Skin Sensitization Test ( the Guinea Pig maximization test) .

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Co., Ltd.

EO Sterilization Validation
. Ethylene Oxide Sterilization Residuals Test

The tests listed below have demonstrated that the subject device performs as well as the predicate device.

Tip Pull Test .
Switch Operation •
Spring Obturator Operation •
Needle Puncture Force Test .

In each of the above tests, the Unimicro Veress Needle met the

requirements ofthe pre-defined acceptance criteria.

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

8. Substantial Equivalence Determination

The Unimicro 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 Unimax Veress Needle which is the subject of K111441. There are no differences between the two devices that raise any new issues of safety or effectiveness.

The comparison to predicate device as below Table 2.

Item	Proposed Device	Predicate Device
Trade Name	Unimicro Veress Needle	Unimax Veress Needle
510(K) Submitter	Unimicro Medical Systems	Unimax Medical Systems Inc.
	(ShenZhen) Co.,Ltd.
510(K) Number		K111441
Classification	21CFR 884.1730	21CFR 884.1730
regulation	21 CFR 876.1500	21 CFR 876.1500
Classificationand	Class II ,	Class II ,
Code	HIF,FHO	HIF,FHO
Common name	Veress Needle	Veress Needle
Intended Use	The Unimicro Veress Needle	The Unimax Veress Needle is

Table 2 : Comparison to Predicate Device

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	is intended for percutaneousinsertion into the peritonealcavity for the purpose ofinsufflation with carbondioxide to establishpneumoperitoneum prior tothe placement of trocarsduring laparoscopicprocedures.	intended for percutaneousinsertion into the peritonealcavity for the purpose ofinsufflation with carbondioxide to establishpneumoperitoneum prior tothe placement of trocarsduring laparoscopicprocedures.
Consisted	Veress Needle	Veress Needle
Instruments	Obturator	Obturator
Models	MND 11200,MND 11500	xVN Series
Length	120mm,150mm	120mm,150mm
Sterilization	EO Sterilized	EO Sterilized
Disposable	Yes	Yes
Principles of operation	Connect the device to theinsufflators with insufflationtubing, insufflating withcarbon dioxide to establishpneumoperitoneum	Connect the device to theinsufflators with insufflationtubing, insufflating withcarbon dioxide to establishpneumoperitoneum
Safety standards	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-7:2008ISO 10993-10:2010ISO 10993-12:2012ISO 11135-1:2007	ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-12ISO 11135-1
Performance standards	Not Applicable	Not Applicable
Compared performance testing	• Tip Pull Test• Switch Operation• Spring Obturator Operation	• Tip Pull Test• Switch Operation• Spring Obturator Operation

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Image: Unimicro Medical Systems (ShenZhen) Co., Ltd.
• Needle Puncture Force	• Needle Puncture Force

Test

9. Conclusion

Based upon the non-clinical performance and safety tests, it can be concluded that the Unimicro Veress Needle is as safe and effective as the predicate device. Therefore, Unimicro Veress Needle is substantially equivalent to the Unimax Veress Needle.

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.