The design of SOLOS ENDOSCOPY made/marketed endoscope K983538 is identical in every way as the scope approved for intended uses that are listed in this document. The physical characteristics, except for miniaturization, are identical as the approved device and this predicate device has been accepted with respect to: performance specifications, composition, intended use, technology employed, biocompatibility, manufacturing, QC, physical testing, etc.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device, the Miniature Endo/Laparoscope, submitted by DOFI Communications. The core of this submission is to establish Substantial Equivalence to an already legally marketed predicate device (Solos Endoscopy's K983538).

Crucially, a 510(k) submission for substantial equivalence does not typically involve a new clinical study to prove the device meets specific acceptance criteria in the same way a novel device might via a de novo or PMA pathway. Instead, it demonstrates that the new device is as safe and effective as a predicate device. Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.), sample sizes, ground truth, and human-in-the-loop studies is not present in this document because it's not relevant to a substantial equivalence claim based on identicality.

The document explicitly states that the DOFI Communications device is "IDENTICAL in every way" to the Solos Endoscopy device (K983538). This means it is assumed to share the same performance characteristics, safety profile, and efficacy as the predicate device.

However, I can extract the information relevant to how the substantial equivalence was claimed, which acts as the "proof" in this context.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence due to the nature of the 510(k) claim:

Acceptance Criteria and Study Proving Device Meets Criteria

The fundamental "acceptance criterion" for this 510(k) submission is demonstrating Substantial Equivalence to a legally marketed predicate device. The "study" proving this is the comparison report provided by DOFI Communications, asserting the device's identicality to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the claim of "identicality" to a predicate device, specific performance metrics for the DOFI device are not reported independently. The "acceptance criteria" are not quantitative performance thresholds for a novel study, but rather a qualitative assessment of identicality/similarity to the predicate.

Acceptance Criterion (for Substantial Equivalence)	Reported Device "Performance" / Justification
Physical Characteristics	"IDENTICAL in every way" to predicate K983538 (except for miniaturization, which is deemed to have "no impact on the safe use and/or effectiveness")
Performance Specifications	Deemed identical to predicate K983538
Composition	Deemed identical to predicate K983538
Intended Use	"IDENTICAL" to predicate K983538 and other similar devices; "Use for visualization inside the human body to view surgical procedure(s), by physician."
Technology Employed	Deemed identical to predicate K983538
Biocompatibility	Deemed identical to predicate K983538
Manufacturing	Deemed by DOFI to be identical in process to predicate K983538
Quality Control (QC)	Deemed by DOFI to be identical in process to predicate K983538
Physical Testing	Deemed by DOFI to be identical in process to predicate K983538
Safety and Effectiveness	Minor changes (miniaturization) have "no impact on the safe use and/or effectiveness of the device." Wide, general use of similar devices demonstrates safe use.

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

Not applicable. This submission is based on a claim of identicality to a predicate device, not on a new clinical study with a test set of data. The "test set" here is the design and specifications of the DOFI device being compared to the existing specifications of the predicate device (Solos Endoscopy K983538).
The provenance of underlying data for the predicate device's approval (K983538) is not detailed in this document.

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

Not applicable. No new "ground truth" establishment for a test set was required for this substantial equivalence claim. The "ground truth" is effectively the established safety and efficacy of the predicate device as determined by its original approval.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was used. The substantial equivalence was assessed by the FDA against the provided documentation from DOFI Communications confirming the identicality to the predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not conducted as this is a substantial equivalence claim based on physical and functional identicality, not a new assessment of AI or reader performance.

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

No. This is not an AI device, and no standalone performance study in this context was performed or required.

7. The Type of Ground Truth Used

Implicitly, the ground truth is the established safety and effectiveness profile of the predicate device (Solos Endoscopy K983538) and other similar legally marketed endoscopes. The DOFI device is deemed safe and effective because it is "identical" to these already-approved devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device; therefore, there is no "training set" in the context of an algorithm.

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

Not applicable. As above, there is no training set for an algorithm in this context.

Summary

{0}------------------------------------------------

JAN 1 9 1999

DOFI COMMUNICATIONS provides the following 510(k) Summary:

We have taken the terminology from the Reference Manual-"Pre-market Notification 510(k): Regulatory Requirements for Medical Devices" (FDA 92-4158).

Summarv

DOFI Communications confirms that the Miniature Endo/Laparoscope listed in this 510(k) is IDENTICAL in every way to the device marketed by Solos Endoscopy under K983538 and therefore this device is Substantially Equivalent, in terms of physical characteristics, to the legally marketed devices already in commercial distribution, These other devices are made/marketed by Solos Endoscopy, Inc., Mitsubishi Inc. America, and no less than 20 other companies with similar devices with very similar characteristics. These other devices now under commercial distribution are K936857. and K935834. Others with very similar characteristics are listed and under commercial distribution by Omega under K91109C and Candela Laser under K910732. Other manufacturer's, such as, but not limited to; Fujinon, Olympus, Baxter, Stryker, Linyatec, Karl Storz et al, market similar devices and are cited in this document as having similar and verv comparable products

The design of SOLOS ENDOSCOPY made/marketed endoscope K983538 is identical in every way as the scope approved for intended uses that are listed in this document. The assessment of this device, from DOFI COMMUNICATIONS', point of view is as follows: The physical characteristics, except for miniaturization, are identical as the approved device and this predicate device has been accepted with respect to: performance specifications, composition, intended use, technology employed, biocompatibility, manufacturing, QC, physical testing, etc. These above minor changes have no impact on the safe use and/or effectiveness of the device.

For information purposes and completeness DOFI COMMUNICATIONS has also cited the other legally marketed devices ie: (Olympus, Pentax, etc.), in this filing to illustrate the wide, general use of many other similar devices. This wide use has led to the safe use of the device in many practitioner's hands for the same intended use-Use for visualization inside the human body to view surgical procedure(s), by physician.'

DOFI COMMUNICATIONS, therefore, contends there is Substantial Equivalence of the device and the device's Intended Uses.

{1}------------------------------------------------

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 1999

Mr. Tony Anthony President and Chief Executive Officer DOFI Communications, Inc. 150 West 51st Street, Suite 1108 New York. New York 10019

Re: K983527

Trade Name: Miniature Endo/Laparoscope Regulatory Class: II Product Code: GCJ Dated: December 22, 1998 Received: January 11, 1999

Dear Mr. Anthony:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Mr. Tony Anthony

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

{3}------------------------------------------------

Page 1 of 1

510(k) #: K983527

Device Name: Miniature Endo/Laparoscope

Indications for Use:

The Indications for this device use is for medical practitioner needing visualization of soft tissue, either through a natural orifice or incision.

Intended Use:

'Use for visualization inside the human body to view surgical procedure(s), by physician. '

Prescription Use
(Per 21 CFR 801.109)

ccelo

(Divisio Division of General Restor 510(k) Number

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.