Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures.
Facilitate suture handling and placement.

Device Description

The DigiCAP is an accessory to surgeon's gloves. This product is made from a resin and is of a rigid configuration whereas surgeons gloves are usually prepared from latex or vinyl materials.

AI/ML Overview

The provided document is a 510(k) summary for the DigiCAP™, an accessory to surgeon's gloves, seeking to demonstrate substantial equivalence to legally marketed predicate devices. It does not contain information regarding a specific study to establish detailed acceptance criteria or present performance data for the device itself. Instead, it focuses on comparing the DigiCAP™ to existing devices based on intended use and technological characteristics.

Therefore, many of the requested elements for describing the acceptance criteria and a study proving the device meets them cannot be extracted from this document.

Here's an analysis of what can and cannot be provided:

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

Cannot be provided. The document does not define specific performance acceptance criteria (e.g., puncture resistance levels, durability standards) for the DigiCAP™ or present quantitative performance results against such criteria. The "Substantial Equivalence" section broadly states that "Descriptive information provided shows that the materials from which the DigiCAP is made provide the protection claimed."

2. Sample size used for the test set and the data provenance

Cannot be provided. The document does not describe a test set or data derived from one. The evaluation is based on comparison to predicate devices and material characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Cannot be provided. No expert-derived ground truth for a test set is mentioned.

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

Cannot be provided. No adjudication method is mentioned as there is no described test set that would require one.

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

Cannot be provided. This is not relevant to the device described. The DigiCAP™ is a physical medical device (an accessory to surgeon's gloves), not an AI or software-as-a-medical-device (SaMD) that would involve human "readers" or AI assistance.

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

Cannot be provided. This is not relevant. The DigiCAP™ is a physical device, not an algorithm.

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

Cannot be provided. No specific ground truth methodology for performance evaluation is described. The "ground truth" for its regulatory submission is effectively the established safety and effectiveness of predicate devices to which it is compared.

8. The sample size for the training set

Cannot be provided. There is no mention of a training set as this is not an AI/ML device.

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

Cannot be provided. Not applicable.

Summary derived from the provided text:

The document describes the DigiCAP™ as an accessory to a surgeon's glove, intended to provide needlestick and suture/scalpel protection during surgical procedures and facilitate suture handling. Its regulatory submission (K012199) is based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically "Gimbel Puncture Resistant Powder Free Surgical Glove cleared under K003063" and "Percuguard cleared under K992539."

The claim of substantial equivalence is based on:

Same intended use: To provide protection of the patient and surgeon from needle-sticks and scalpel cuts, and protect the integrity of the glove to body fluids.
Similar technological characteristics: While made from a different material (rigid polymer resin) compared to typical latex/vinyl gloves, the product is described as providing the "protection claimed" through its material properties. All materials are tested for biocompatibility.
Descriptive information: Showing that the materials provide the claimed protection and are substantially equivalent in safety and effectiveness to similar products.

The "study" in this context is the submission of descriptive information and comparative analysis demonstrating substantial equivalence, rather than a clinical trial or performance study with defined acceptance criteria and performance metrics.

Summary

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DEC 1 9 2001

K012199

XII. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. Sept. 10, 1996. [Separate Pages]

I.* Submitter: Dr. Syed Rizvi, Humana USA, Inc., Reno, Nevada. Ph: 661-761-9771.

II. Classification Names and Numbers: Accessory to surgeon's gloves, KGO.

III. Common/Usual Name: Accessory to Surgeon's gloves.

IV. Proprietary Names: DigiCAP™

V. Establishment Registration Number: In progress

VI. Classification: Surgeon's gloves were classified by the General and Plastic Surgery Panel under CFR 878.4460 and are Class I, restricted.

VII. Substantial Equivalence: The DigiCap™ is an accessory to surgeon's gloves, Code HGO, VII. Substantial Equivalent to the many surgeon's gloves cleared under the 510(k) process and is most similar to the "Gimbel Puncture Resistant Powder Free Surgical Glove cleared under K003063. It is also similar to the Percuguard cleared under K992539 but differs from it in that the It is also similar to the receard enceramination glove during injection and examination I credgand 13 milended for ass mand for use by surgeons during various surgical procedures.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use, to provide protection of the patient and surgeon 1. These produces have needle-sticks and scalpel cuts during surgical procedures. Both provide a tough, repellant surface to protect the fingers of surgical personnel. Since the Dour provide a tooging top of the glove, it also protects the integrity of the glove to body fluids.
The technological characteristics for this product are similar to those for the predicate devices and similar products currently on the market. This product, however, is made from a and - smillians presin and is of a rigid configuration whereas surgeons gloves are usually prepared from latex or vinyl materials. All materials are tested for biocompatibility.
Descriptive information provided shows that the materials from which the DigiCAP is made provide the protection claimed and are substantially equivalent in safety and effectiveness to those of similar products, used for similar purposes, currently on the market.
The FDA "Decision-Making Process" chart was also used and appears in Attachment V.

[End of Summary]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2001

Humana USA, Incorporated C/O Dr. H.N. Dunning Dr. H.N. Dunning 8309 Bryant Drive Bethesda, Maryland 20817

Re: K012199

Trade/Device Name: Digicap Regulation Number: 878.4460 Regulation Name: Needle Accessory Regulatory Class: I Product Code: KGO Dated: October 30, 2001 Received: November 5, 2001

Dear Dr. Dunning:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.

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Page 2 - Dr. Dunning

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); 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.

This letter will allow you to begin marketing your device as described in your Section 11ms letter will and in your of 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 11 you distre up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the riot may of stance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VIII.1 Indications for Use: [Separate Page]

510(k) Number: KO) 2199

Device Name: DigiCAP™

DigiCap™ is a protective finger guard accessory to the surgeon's glove.

Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures.
Facilitate suture handling and placement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__
(Optional format 1-2-96)

Qun S. Lim
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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De ! | Olik) Number

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.