These kits are a convenience assemblage of sterile, disposable, legally marketed medical devices intended for use by trained physicians for Healthcare Manufacturing ophthalmic surgical procedures. National Corporation does not cause or promote new intended uses for the devices within these kits.

Device Description

The National Healthcare Manufacturing custom ophthalmic procedure trays or kits are sterile, disposable, medical device convenience kits. These kits are custom to the customer, whose specifications determine the devices included in the kit.

AI/ML Overview

The provided document is a 510(k) summary for the National Healthcare Manufacturing Corp. Ophthalmic Kit or Tray, submitted to the FDA in 1997. This document details the device's classification, intended use, technological characteristics, and a list of components, primarily for the purpose of demonstrating substantial equivalence to a predicate device.

Crucially, this document is a regulatory submission for a medical device kit, not an AI/ML device. Therefore, the standard acceptance criteria and study descriptions typically associated with AI/ML device performance (like accuracy, F1-score, sample sizes for training/test sets, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this kit revolve around demonstrating substantial equivalence to a legally marketed predicate device, ensuring the device is safe and effective for its stated intended use. This is achieved through comparisons of materials, packaging, sterilization, and intended use, rather than performance metrics.

Based on the provided text, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device because the document describes a sterile, disposable ophthalmic procedure kit, not an AI/ML medical device.

However, I can extract information relevant to the device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable to a non-AI kit):

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device "Performance" / Characteristics
Substantial Equivalence to Predicate Device	The NHMC Custom Ophthalmic packs are "substantially identical in materials" to "The Nithous Custom Ophulanas Fpackaging, Trays legally marketed under K880961." The document states: "There are no differences in the characteristics of the subject device and the predicate." This is the primary "performance" metric for a 510(k) non-AI device.
Intended Use	"These kits are a convenience assemblage of sterile, disposable, legally marketed medical devices intended for use by trained physicians for Healthcare Manufacturing ophthalmic surgical procedures. National Corporation does not cause or promote new intended uses for the devices within these kits." The FDA's concurrence on this intended use is implicit in their approval letter.
Sterility	"The National Healthcare Manufacturing custom ophthalmic procedure trays or kits... are sterile, disposable..." This is a stated characteristic of the device.
Disposable Nature	"...disposable..." This is a stated characteristic of the device.
Device Components	The document provides a detailed list of components (e.g., cannula, towel cap, eye pad, various needles, gauze, syringes, drapes, etc.) indicating what is included in the kit. The "performance" here is that the kit contains the listed items suitable for ophthalmic procedures, matching or being equivalent to the predicate device in content.
Regulatory Classification	The devices within the kit are Class I and Class II. The FDA confirms the regulatory class for the submitted device (II) and the product codes (78 KKX, 86 HMX, 86 HOY, 86 HNM, 86 HQR). This is an "acceptance" criterion in the sense that the FDA confirms the appropriate regulatory pathway has been followed.
Compliance with General Controls	The FDA's letter states that marketing is "subject to the general controls provisions of the Act," including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This is an ongoing "acceptance" requirement, verified through GMP inspections.

The following numbered points cannot be answered from the provided text as they relate to AI/ML device studies, which are not described in this document.

Sample sizes for the test set and data provenance: Not applicable.
Number of experts and their qualifications for ground truth: Not applicable.
Adjudication method for the test set: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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2011-04-2342811 2 . 02

REVISED 5/28/97

Attachment 1 510(k) Summary

JUN - 4 1997

.K971465

National Healthcare Manufacturing Corp. Ophthalmic Kit or Tray

Submitter Information:

Alice Gibson General Manager National Healthcare Manufacturing Corp. 251 Sulteaux Crescent Winnipeg, Manitoba R3J 3C7 Canada

510(k) Summary Prepared by:

Carolann Kotula Official Correspondent for NHMC c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021

Phone:	(516) 482-9001
Fax:	(516) 482-0186

Date 510(k) Summary Prepared:

April 7, 1997

Name/Classification of the Device:

Classification Name:

Surgical Procedure Packs

Common Name:

Pack, Tray, or Kit Ophthalmic

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

Attachment 1 510(k) Summary

Proprietary Name:

National Medical Healthcare custom Ophthalmic kits or trays

Classification:

A classification for these devices could not be located, however, the medical devices within the kits or trays are Class I and Class II devices

Identification of the Legally Marketed Device to which the Submitter Claims Equivalence:

The NHMC Custom Ophthalmic packs . are substantially identical in materials. The Nithous Custom Ophulanas Fpackaging, Trays legally marketed under K880961.

Description of the Subject Device:

The National Healthcare Manufacturing custom ophthalmic procedure trays or kits I he National Healtheare Manatal device convenience kits. National Healthcare
are sterile , disposable , medical device convenience bit in Canada as: Cataract are sterlie , disposable , medical device convention to the eustomer , whose Ophthalmology Pack, and others. These kits are custom to the customer, whose Ophinalmology Fack, and others: "Incose included in the kit. Please see attached list.

Intended Use of the Subject Device;

These kits are a convenience assemblage of medical devices intended for use by These Kits are a convenience assemblage or and procedures. National Healthcare trained physicians for opinnianiae surgister promote new intended uses for the devices within these kits.

Technological Characteristics of the Subject Device:

There are no differences in the characteristics of the subject device and the predicate.

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Raw material Number	Description	Quantity
17-809-001	cannula 18 ga	1
10-014-001	towel cap	1
11-328-003	eye pad	2
11-326-005	eye shield clear	1
11-901-001	gown sonbra	1
11-901-002	gown id sterile back	1
12-252-009	beaver blade 7816	1
12-443-001	skin marker with tape	1
12-505-001	medicine cup 30 ml	1
12-505-002	medicine cup 60 ml	1
12-743-003	needle 2.0 x 5/8	3
12-748-007	needle 23 ga x 1	1
12-745-009	needle 19 x 1 1/2"	1
12-745-012	needle angled 19 ga	1
12-745-014	needle 27 ga x 1/2	1
12-745-015	needle angled 27 ga	1
13-000-001	label	4
13-066-002	jumbo applicator	1
13-065-003	cotton tipped applicator	20
13-700-001	gauze 5 x 6 8 ply	5
13-700-006	gauze 3x3 8 ply	5
13-704-003	eye spear wick cel	10
13-735-007	ziploc bag	1
13-735-025	3 compartment tray	1
13-734-032	header bag 14 x 16	1
13-040-003	syringe 6 ml	1
13-940-005	syringe 3 ml	1
14-077-009	absorbent towel	1
14-424-001	Poly Bag	1
16-013-002	saline 50 ml	1
16-013-011	solution pvp paint 2 oz	1
15-045-002	lap sponge 18 x 18	5
15-671-007	crepeffe cover 21x 30	1
15-671-000	cathora coover 7 x96	1
18-846-001	back table cover 44 x 78	1
5-648-006	mayo stand cover	1
5-648-025	eye drape 40 x48 aperture	1
5-646-027	drape 3/4 sheet	1
5-846-035	head drape	1
4-874-001	tray b/l ambidextrous	1

・

; :

TOTAL P.02

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 997

Ms. Alice Gibson National Healthcare Manufacturing Corp. c/o Carolann Kotula MDI Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021

Re: K971465 Trade Name: Ophthalmic Pack/Tray/Kit Regulatory Class: II Product Code: 78 KKX, 86 HMX, 86 HOY, 86 HNM, 86 HQR Dated: Apil 17, 1997 Received: Apil 22, 1997

Dear Ms. Gibson:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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Page 2 - Ms. Alice Gibson

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. I ----

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) 594-4613. 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 at (301) 443-6597.

Sincerely yours,

Aleryl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NHMC Ophthalmic Kit or Tray Attachment 3

510(k) Number (if known)

National Healthcare Manufacturing Corporation Custom Device Name: Ophthalmic Kit or Tray

Indications for Use:

(Please Do Not Write Below this Line/Continue on Another Page if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Williams

(Division Sign-Off)
Division of Ophthalmic Devices

Division of Ophthalmic Devices
510(k) Number K971465

Prescription Use (per 21 CFR 801.109)

Over the Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 886.4750 Ophthalmic eye shield.

(a)
Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.(b)
Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.