The MINI-TONG instruments are minimally invasive devices. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.

AI/ML Overview

The provided FDA 510(k) summary for the "MINI-TONG" device primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It does not present a detailed study with acceptance criteria and reported device performance metrics in the way that would typically be seen for a new, complex diagnostic or therapeutic device requiring extensive performance testing.

The document states: "We believe the addition of this new jaw configuration is a minor expansion to a product family that already has 510(k) clearance. The subject device is composed of biocompatible materials and the sterilization process has been validated." This suggests that the primary "study" or justification for equivalence relied on the established performance of existing predicate devices and basic material/sterilization validation.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this submission.

Here's a breakdown of what can be extracted and what is explicitly not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Grasping/Clamping Effectiveness	Not explicitly stated as numerical criteria in this document. Implied to be equivalent to predicate devices.	"The devices are used for temporary grasping and clamping of soft tissue and small tubular structures during minimally invasive procedures." This function is implicitly deemed equivalent to predicate devices. The document states: "We believe the MINI-TONG instruments are substantially equivalent to the predicate devices have the same technological characteristics as the predicate devices including identical handle design and safety interlock as well as are composed of biocompatible stainless steel."
Biocompatibility	Implicit standard for medical devices.	"The subject device is composed of biocompatible materials."
Sterilization Efficacy	Implicit standard for sterile medical devices.	"the sterilization process has been validated."
Safety	Implicit standard for medical devices; prevention of inadvertent retraction during use.	"The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use." This is a design feature intended to meet safety requirements.

Missing Information: Specific quantitative acceptance criteria (e.g., minimum grasping force, maximum tissue damage, durability under specific loads) and detailed performance data (e.g., actual measured grasping force, results of biocompatibility tests, sterilization validation reports) are not provided in this summary.

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

No specific "test set" sample size for functional performance is mentioned in the provided text.
No details on data provenance (e.g., country of origin, retrospective/prospective) related to a performance study are provided. The justification for equivalence relies on the known performance of predicate devices.

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

Not applicable as no specific test set requiring expert-established ground truth is described in this submission. The "ground truth" for substantial equivalence appears to be based on the established safety and effectiveness of the predicate devices and the technological similarity.

4. Adjudication Method for the Test Set

Not applicable as no specific test set requiring adjudication is described.

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

No MRMC comparative effectiveness study was mentioned or implied. This type of study is typically for diagnostic devices or devices where human-AI interaction is central to the performance. The MINI-TONG is an instrument, not a diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The MINI-TONG is a manual surgical instrument, not an algorithm, so independent algorithmic performance is not relevant. Its performance is always human-in-the-loop.

7. Type of Ground Truth Used

For the purpose of substantial equivalence, the "ground truth" implicitly relies on:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (Mini Lap Instruments - K070686, U.S. Surgical Modified Hand Instrument Devices K960748, Solos Endoscopy 10mm Atraumatic Grasping Forcep and 5mm Grasping Forcep K900948 / K900958).
- Design & Material Standards: Compliance with biocompatibility standards and validated sterilization processes.
- Functional Description: The device's described ability to perform its intended function of grasping and clamping.

8. Sample Size for the Training Set

Not applicable. As a physical instrument, there is no "training set" in the context of an AI/ML algorithm. The design and validation are based on engineering principles and testing appropriate for a mechanical device.

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

Not applicable, as there is no "training set." The performance characteristics are derived from engineering design, material selection, manufacturing processes, and comparison to predicate devices, rather than machine learning training.

Summary Caveat: This analysis is strictly based on the provided text, which is an FDA 510(k) summary. Such summaries are often high-level and refer to more detailed internal documentation (e.g., test reports for biocompatibility, sterilization validation, mechanical testing) that would contain the specific acceptance criteria and detailed performance data. This document's primary purpose is to articulate the basis for claiming substantial equivalence, not to fully detail all underlying engineering and performance tests.

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 consists of a stylized eagle or bird-like figure with three parallel lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Mini Lap Technologies, Inc. % Orchid Design Mr. Joseph Azary 80 Shelton Technology Center Shelton, CT 06484

JUL 2 7 2015

Re: K101101 Trade/Device Name: Mini-Tong Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): June 12, 2010 Received (Date on orig SE Itr): June 16, 2010

Dear Mr. Azary,

This letter corrects our substantially equivalent letter of July 23, 2010.

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

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Page 2 -

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 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 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. 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,

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

K 10/10/ 510(k) Number (if known):

Device Name: MINI-TONG

Indications For Use:

The devices are used for temporary grasping and clamping of soft tissue and small tubular structures during minimally invasive procedures.

. ·

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

(Division Sign-O (Division Sign-On)
Division of Surgical, Orthopedic, Division of Suits of Suices

510(k) Number

Page 1 of 1

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/ollool

Image /page/3/Picture/1 description: The image shows the logo for Mini Lap Technologies Inc. The logo includes the text "Mini Lap Technologies Inc." in a bold, sans-serif font. To the left of the text is a stylized graphic of an atom. The number 1.4 is located in the bottom right corner of the image.

JUL 2 8 2010

510 (k) Summary

Submission Type:

Traditional 510(k)

Date Prepared [21 CFR 807.92(a)(1)] [Revised July 12, 2010]

Submitter's Information [21 CFR 807.92(a)(1)]

Regulatory Contact Joseph Azary Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com

Sponsor / Manufacturer Mini Lap Technologies Inc. 88 Ashford Avenue Dobbs Ferry, NY 10522

Tel: (914) 591 8400

FDA Establishment Registration is 3007123990

P. 1 of 3

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Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)}

Trade Name

MINI-TONG Instruments ●
Device Common, Usual, or Classification Names
Laparoscopic Instruments, Retractors, Cannula, Trocar, Manual Surgical Instruments o

Classification Panel

Classification of this device would fall under the responsibility of the Gastroenterology / Urology o panel.

Class

・

Based on our research we believe the device is a class 2 device classified under the following Product Codes:

O KOG, 21 CFR 876.1500, Endoscope Accessories
KOA, 21 CFR 876.4730 Manual Surgical Instruments o
FBQ, 21 CFR 878.5090 Trocar 0

Predicate Device 121 CFR 807.92(a)(3)]

O Mini Lap Instruments - K070686
U.S. Surgical Modified Hand Instrument Devices K960748 O
Solos Endoscopy 10mm Atraumatic Grasping Forcep and 5mm Grasping Forcep K900948 / 0 K900958

Description of the Device [21 CFR 807.92(a)(4)]

The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.

P. 2 of 43

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Intended Use |21 CFR 807.92(a)(5)]

The devices are used for temporary grasping and clamping of soft tissue and small tubular structures during minimally invasive procedures.

Technological Characteristics [21 CFR 807.92(a)(6)]

We believe the MINI-TONG instruments are substantially equivalent to the predicate devices have the same technological characteristics as the predicate devices including identical handle design and safety interlock as well as are composed of biocompatible stainless steel.

Performance Data [21 CFR 807.92(b)(1)|

We believe the addition of this new jaw configuration is a minor expansion to a product family that already has 510(k) clearance. The subject device is composed of biocompatible materials and the sterilization process has been validated.

Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.

P. 3 of 3

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.