The LaparoLight™ 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 LaparoLight™ Veress Needle is a Veress needle that includes an LED indicator. This product is used to establish pneumoperitoneum prior to start of laparoscopic procedure. LaparoLight™ Veress Needle is available in two lengths: 120mm and 150mm to use in different size patients and applications. LaparoLight" Veress Needle is provided sterile and intended for single-use only in a healthcare facility/hospital.

LaparoLight™ Veress Needle includes a spring loaded blunt stylet mechanism. When pressure is applied on blunt tip, it retracts and allows the sharp edge of cannula to cut through the tissue. Product also includes a slip sheet which when pulled activated the LED indicator. LED will turn ON and stay ON as long as the blunt tip of the product is extended forward past sharp edge of cannula. Thus during the puncture of peritoneum wall the LED will turn OFF while there is a pressure against blunt tip and turn back ON when cannula has entered a cavity allowing the blunt tip to spring forward.

In addition LaparoLight™ Veress Needle includes a luer lock for syringe connection to perform saline flow test and insufflation tubing for gas delivery. Stop cock is present downstream of luer lock to control the flow of liquid or gas through the needle with possible positions ON and OFF.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the LaparoLight™ Veress Needle. It does not present acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-driven diagnostics. Instead, it describes tests performed to demonstrate substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

However, I can extract the relevant information regarding performance data presented for the substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like the Veress Needle, "acceptance criteria" are usually framed as meeting design specifications, industry standards, and demonstrating equivalence to a predicate device through various tests.

Acceptance Criteria Category	Reported Device Performance / Evaluation	Notes
Biocompatibility	Complies with ISO 10993-1. Passed: In Vitro Cytotoxicity, Maximization Sensitization, Intracutaneous Reactivity, Systemic Toxicity Testing, Rabbit Pyrogen Testing.	The device is considered to contact Tissue/bone/dentin for a limited duration (< 24hrs). These tests are standard for evaluating biological safety of materials that contact the body.
Electrical Safety	Complies with AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012.	Standard for electromedical equipment safety. The LaparoLight™ Veress Needle includes an LED indicator, necessitating electrical safety testing.
EMC (Electromagnetic Compatibility)	Complies with IEC 60601-1-2 Edition 4.0 2014-02.	Standard for electromedical equipment immunity and emissions. Relevant due to the LED component.
Design Validation	Operates as intended. Test included: puncturing of simulated tissue, operation of blunt tip position indicator, saline and gas delivery.	Confirms the basic functional requirements of the device.
Force Equivalency	Force of spring-loaded blunt stylet and puncture force are similar to the predicate device.	Demonstrates functional similarity to the predicate device in terms of mechanical forces.
Tip Pull Test	Equivalent to predicate device performance regarding strength of bond between components.	Confirms structural integrity similar to the predicate device.
Switch Operation Test	Equivalent to predicate device performance by testing control of gas flow with stop cock/flow controller assembly.	Confirms the functionality of gas flow control similar to the predicate device.
Spring Obturator Operation Test	Equivalent to predicate device performance – testing covered "click" of the needle and blunt tip extension once the needle enters open internal volume.	Confirms the haptic and functional feedback mechanism similar to the predicate device.
Puncture Force Test	Equivalent to predicate device performance – testing covered puncture force required to puncture tissue simulator.	Confirms the mechanical force required for insertion similar to the predicate device.

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

Sample Size: Not specified in the document for any of the performance tests. These are typically bench tests, and the "sample size" would refer to the number of devices tested.
Data Provenance: Bench testing performed on the device itself.
- No patient data (retrospective or prospective) is involved, as this is a physical medical instrument, not a diagnostic algorithm.
- No country of origin of data is specified, as it's laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This is a physical device, and "ground truth" as it relates to expert consensus for diagnostic tasks is not relevant. The "ground truth" for these tests would be the design specifications and established engineering principles.

4. Adjudication Method for the Test Set

Not Applicable. Again, this concept applies to diagnostic or interpretative tasks where expert agreement is needed to establish a correct answer. For bench testing of a physical device, the outcome is typically objectively measurable (e.g., force, electrical parameters).

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

No. This is a physical surgical instrument and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.

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

No. This device is not an algorithm. It's a physical medical instrument used by a human surgeon. Standalone performance as it relates to AI is not applicable.

7. The Type of Ground Truth Used

Engineering Specifications and Industry Standards: For the performance tests (e.g., electrical safety, EMC, biocompatibility), the "ground truth" is compliance with recognized engineering standards (e.g., ISO, AAMI/ANSI, IEC) and the device's own design specifications. For the comparative tests (force, bond strength), the "ground truth" is equivalence to the performance of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

May 18, 2017

Buffalo Filter, LLC % Mark A. Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313

Re: K171139

Trade/Device Name: LaproLight™ Veress Needle Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: Unclassified Product Code: HIF Dated: April 17, 2017 Received: April 18, 2017

Dear Mark A. Job:

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 (reporting of medical

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device-related 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" (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 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,

Benjamin/R. Fisher -S

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)

K171139

Device Name LaparoLight™ Veress Needle

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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K171139 page 1 of 4

Image /page/3/Picture/1 description: The image shows the logo for Buffalo Filter Filtration Group. The logo features a spiral of green and blue dots on the left side. To the right of the spiral is the company name, "BUFFALO FILTER," in blue, with "Filtration Group" in gray underneath.

510(k) Summary For LAPAROLIGHT™ VERESS NEEDLE

Submitter:

Buffalo Filter, LLC 5900 Genesee Street Lancaster, NY 14086 Phone: (716) 835-7000 Fax No: (716) 835-3414 FDA Registration number: 1319744

Contact:	Kyrylo Shvetsov
	Program Manager, NPD
	Senior Engineer
	Telephone: (716) 835-7000
	Fax No: (716) 835-3414

Prepared Date: March 20, 2017

1. Device Name

Trade Name:	LaparoLight™ Veress Needle, models LLVN12001and LLVN15001
Common/Usual Name:	Veress Needle
Classification Name:	Insufflator, Laparoscopic (21 CFR 884.1730,Product Code: HIF and FHO

2. Predicate Device

Buffalo Filter claims substantial equivalence to:

Unimax Medical Systems Inc, Unimax Veress Needle (K111441)

This predicate device has not been subjected to a design-related recall.

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3. Description of Device

4. Intended Use

The LaparoLight M 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.

ട്. Description of Substantial Equivalence

The subject and predicate device have the same intended use.

At a high level, the subject and predicate devices are based on following same technological elements:

Spring loaded blunt stylet - used to protect internal organs from sharp of cannula.
Blunt tip exposure indicator an indicator that shows to the user if blunt tip is ● extended or retracted
. Luer Lock - connection point for syringe to perform saline test and insufflation tubing for CO2 gas delivery
Stop Cock - to control gas passage through the needle

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The following technological differences exist between the subject and predicate device:

Type of Blunt tip exposure indicator LaparoLight™ Veress Needle contains ● an LED instead of a red marker painted on the needle hub that shows if blunt tip is extended
Slip Sheet for product activation prior to use .

The differences in technology do not raise different questions of safety and effectiveness.

Performance Data 6.

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the LaparoLight™ Veress Needle was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests:

· In Vitro Cytotoxicity
· Maximization Sensitization
Intracuteneous Reactivity
· Systemic Toxicity Testing
· Rabbit Pyrogen Testing

The LaparoLight™ Veress Needle is considered a device that contacts the Tissue / bone / dentin for a limited contact duration (less than 24hrs). The test results demonstrate that the subject device is biocompatible.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the LaparoLight™ Veress Needle. The system complies with AAMI/ANSI ES 60601-1:2005/(R)2012 And A 1:2012 standard for electrical safety and IEC 60601-1-2 Edition 4.0 2014-02 standard for EMC.

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Performance Testing - Bench

The following bench tests were performed for this submission, and the subject device passed all tests.

LaparoLight™ Veress Needle Design Validation ●
Design Validation was performed to verify that the LaparoLight™ Veress Needle product can operate as intended. Validation test included puncturing of simulated tissue, operation of blunt tip position indicator, saline and gas delivery.
LaparoLightTM Veress Needle Force Equivalency
Force testing was conducted to confirm that the force of the spring loaded blunt stylet and puncture force are similar to the predicate device
LaparoLight™ Veress Needle Tip Pull Test ●
Testing to confirm equivalence to predicate device performance with regard to strength of bond between components
LaparoLight™ Veress Needle Switch Operation Test ●
Testing to confirm equivalence to predicate device performance by testing control of gas flow with stop cock/flow controller assembly
LaparoLight™ Veress Needle Spring Obturator Operation Test ●
Testing to confirm equivalence to predicate device performance – testing covered "click" of the needle and blunt tip extension once the needle enters open internal volume
LaparoLight™ Veress Needle Puncture Force Test ●
Testing to confirm equivalence to predicate device performance – testing covered puncture force required to puncture tissue simulator

7. Conclusion

The performance testing demonstrates that the LaparoLight™ Veress Needle is substantially equivalent to 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.