(43 days)
Not Found
No
The summary describes a convenience kit of pre-packaged, legally marketed medical devices for ophthalmic surgery. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The document describes the device as a kit of legally marketed medical devices, not a therapeutic device itself. It does not perform any therapeutic function.
No
The provided text describes "convenience assemblage of sterile, disposable, legally marketed medical devices intended for use by trained physicians for Healthcare Manufacturing ophthalmic surgical procedures." It emphasizes that National Corporation does not cause or promote new intended uses for the devices within these kits. There is no mention of the device being used to identify or analyze a disease or condition, which is the primary function of a diagnostic device. The description explicitly states they are "custom ophthalmic procedure trays or kits," implying they are for performing procedures rather than diagnosing.
No
The device is described as a "convenience assemblage of sterile, disposable, legally marketed medical devices" and "custom ophthalmic procedure trays or kits," indicating it is a collection of physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the kits are for "ophthalmic surgical procedures" performed by trained physicians. This involves direct surgical intervention on a patient, not the examination of specimens in vitro (outside the body).
- Device Description: The description emphasizes that these are "sterile, disposable, medical device convenience kits" containing legally marketed medical devices. This aligns with surgical tools and supplies, not diagnostic reagents or instruments used for testing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVDs are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
78 KKX, 86 HMX, 86 HOY, 86 HNM, 86 HQR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
2011-04-2342811 2 . 02
REVISED 5/28/97
Attachment 1 510(k) Summary
JUN - 4 1997
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.
2
| 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
3
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.
4
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
5
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
(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)