NUMOBAG

• K Number: K981949
• Device Name: NUMOBAG
• Manufacturer: NUMOTECH, INC.
• Date Cleared: 1999-02-03 ( 245 days)
• Product Code: KPJ
• Regulation Number: 878.5650
• Type: Traditional
• Panel: General & Plastic Surgery
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For adjunctive therapy of the following conditions:

• Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
• Decubitus ulcers
• Amputations/infected stumps
• Skin grafts
• Burns
• Frostbite

Device Description

Numobag™

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Numobag™ device, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use.

The letter does not include details about:

• A table of acceptance criteria or reported device performance.
• Sample sizes, data provenance, or ground truth establishment for any test or training sets.
• Information about expert involvement, adjudication methods, or MRMC studies.
• Results from standalone algorithm performance studies.

The document's purpose is regulatory clearance based on substantial equivalence, not a detailed scientific study report.

Summary

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Public Health Service

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3 1999 FEB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Numotech, Inc. c/o Mr. W. Partick Noonan 21800 Oxnard St., Suite 840 Warner Center Plaza Woodland Hills, California 91367

Re: K981949 Trade Name: Numobag™ Regulatory Class: III Product Code: KPJ Dated: August 19, 1998 Received: August 20, 1998

Dear Mr. Noonan:

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.

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.

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Page 2 - Mr. W. Patrick Noonan

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 [phone] 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

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Page

510(k) Number (if known): K981749

NumobagTM Device Name:

Indications For Use:

For adjunctive therapy of the following conditions:

• Skin ulcerations due to diabetes, venous stasis, post 1. surgical infections and gangrenous lesions
• 2. Decubitus ulcers
• Amputations/infected stumps 3.
• 4 -Skin grafts
• 5. Burns
• 6. Frostbite

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981947

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.5650 Topical oxygen chamber for extremities.

(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.