The NormaTec PCD is intended to be used to apply pressure to the extremities. The NormaTec PCD is indicated for use in the treatment of: Lymphedema and other edematous conditions, including Congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda) Post-mastectomy lymphedema Post-infection lymphedema Post-traumatic lymphedema Post-surgical lymphedema Post-radiation-treatment lymphedema Venous insufficiency Venous stasis ulceration and the prevention of: Deep Vein Thrombosis

Device Description

The NormaTec PCD is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics. Both NormaTec's PCD and its predicates are intended to apply pressure to the extremities to treat edematous states like lymphedema, and to prevent deep vein thrombosis. NormaTec's PCD has very similar components as its predicate devices and very similar principles of operation. Each device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, control of pressure applied cyclically and simultaneous treatment of two limbs, if necessary. Like the predicates, pressure is pulsed to the affected limb for a specified period of time, followed by a rest period, according to the physician's prescription.

AI/ML Overview

The NormaTec PCD is a noninvasive pneumatic compression device.

Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria	Reported Device Performance
Electromagnetic Interference	Not specified	"functioned as intended"
Burst Testing	Not specified	"functioned as intended"
Safety Testing	Not specified	"functioned as intended"
Quality Assurance Testing	Not specified	"functioned as intended"

Sample Size and Data Provenance:
- No specific sample size for a test set is mentioned. The document only states that the device "underwent electromagnetic interference testing, burst testing, safety testing and quality assurance testing."
- Data provenance is not specified. The studies were likely conducted internally by NormaTec, Inc.
Number of Experts and Qualifications for Ground Truth:
- Not applicable. The document describes engineering and safety tests, not clinical studies involving expert interpretation of medical data.
Adjudication Method:
- Not applicable. This was not a study requiring adjudication of expert opinions.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. The submission focuses on substantial equivalence to predicate devices and basic engineering/safety performance.
Standalone Performance Study:
- The "Performance Data" section describes direct testing of the device itself ("The NormaTec PCD underwent..."). This can be considered a standalone assessment of the device's basic operational performance and safety characteristics.
Type of Ground Truth Used:
- The "ground truth" for the engineering and safety tests would have been predefined engineering specifications, safety standards, and functional requirements for pneumatic compression devices. For instance, "burst testing" implies a standard for pressure resistance.
Sample Size for Training Set:
- Not applicable. This is not a machine learning or AI-based device, so there is no training set mentioned.
How Ground Truth for Training Set was Established:
- Not applicable, as there is no training set for this device.

Summary

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K013436

DEC 21 2001

510(k) SUMMARY

NormaTec, Inc.'s NormaTec PCD

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 (202) 637-5794 Phone: Facsimile: (202) 637-5910

Jonathan S. Kahan Contact Person:

October 16, 2001 Date Prepared:

Name of Device and Name/Address of Sponsor

NormaTec PCD

Laura Jacobs, M.D., Ph.D. 60 W. Germantown Pike E. Norriton, PA 19401

Common or Usual Name

Noninvasive pneumatic compression device

Classification Name

Compressible Limb Sleeve

Predicate Devices

Camp GCS 2000 (K935998), Wright Linear Pump (K830577), Talley Multicom 500 (K915637), Mego Afek Lymphapress (K810338), and Baxter Pulsatile Anti-Embolism System Pump (PAS II) (K911853).

Intended Use

The NormaTec PCD is intended to be used to apply pressure to the extremities. The NormaTec PCD is indicated for use in the treatment of:

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Lymphedema and other edematous conditions, including

Congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda) Post-mastectomy lymphedema Post-infection lymphedema Post-traumatic lymphedema Post-surgical lymphedema Post-radiation-treatment lymphedema

Venous insufficiency

Venous stasis ulceration

and the prevention of:

Deep Vein Thrombosis

Technological Characteristics and Substantial Equivalence

NormaTec's PCD has very similar components as its predicate devices and very similar principles of operation. Each device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, control of pressure applied cyclically and simultaneous treatment of two limbs, if necessary. Like the predicates, pressure is pulsed to the affected limb for a specified period of time, followed by a rest period, according to the physician's prescription.

Performance Data

The NormaTec PCD underwent electromagnetic interference testing, burst testing, safety testing and quality assurance testing. In all instances, the NormaTec PCD functioned as intended and the results observed were as expected.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol that resembles a stylized human figure embracing the world, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2001

Normatec c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, LLP 555 Thirteenth Street Washington, DC 20004-1109

K013436 Re:

Trade Name: NormaTec PCD Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: II Product Code: JOW Dated: October 16, 2001 Received: October 16, 2001

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the encreated of 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 r ou may, ateres, sportions 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. 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

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Page 2 - Mr. Jonathan S. Kahan

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 510(k) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally premated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 Consumer Assistance 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,

Kathi Tull

ABram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE FORM

510(k) Number (if known): KO 13436

Device Name: _ NormaTec PCD

Indications for Use: The NormaTec PCD is intended to apply pressure to the extremities to treat:

Lymphedema and other edematous conditions, including

Venous insufficiency

Venous stasis ulceration

and to prevent:

Deep Vein Thrombosis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Dalle Teh
Division of Cardiovascular & Respiratory Devices
510(k) Number	K013436

Prescription Use __ X_ (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).