NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS

K971465 · National Healthcare Mfg. Corp. · HOY · Jun 4, 1997 · Ophthalmic

Device Facts

• Record ID: K971465
• Device Name: NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
• Applicant: National Healthcare Mfg. Corp.
• Product Code: HOY · Ophthalmic
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4750
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

Device is a sterile, disposable convenience kit containing various medical instruments and supplies for ophthalmic surgery. Kit components include cannulas, blades, needles, syringes, drapes, gowns, gauze, and solutions. Used in clinical settings by trained physicians to facilitate surgical procedures by providing necessary tools in a single package. Output is the physical kit itself, which streamlines surgical preparation. Benefits include convenience and efficiency for the surgical team.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Convenience kit containing Class I and Class II medical devices. Components include stainless steel needles/cannulas, plastic syringes/trays, and textile drapes/gowns. Sterile, disposable, single-use. No software or electronic components.

Indications for Use

Indicated for use by trained physicians for ophthalmic surgical procedures. No specific patient population or contraindications defined.

Regulatory Classification

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.

Predicate Devices

• Nithous Custom Ophthalmic packaging, Trays (K880961)

Submission Summary (Full Text)

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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: | [phone] |
|--------|----------------|
| Fax: | [phone] |

### 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

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#### 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 | Vendor |
|---------------------|---------------------------|----------|--------|
| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

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:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Williams

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(Division Sign-Off)
Division of Ophthalmic Devices

Division of Ophthalmic Devices
510(k) Number K971465

Prescription Use (per 21 CFR 801.109)

OR

Over the Counter Use

(Optional Format 1-2-96)