(66 days)
No
The document describes a pneumatic compression device with standard components and operation, and explicitly states that it does not mention AI, DNN, or ML.
Yes.
The device is intended for use in the treatment of various medical conditions, including lymphedema, venous insufficiency, and venous stasis ulceration, which positions it as a therapeutic device.
No
The device is described as applying pressure to the extremities for treatment, not for diagnosis. Its purpose is therapeutic (treating lymphedema, venous insufficiency, etc.), not diagnostic.
No
The device description explicitly mentions physical components like an "electrically generated source of compressed air," "tubing," and "sleeves," indicating it is a hardware-based device with potential software control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "apply pressure to the extremities" for the treatment of various conditions like lymphedema and venous insufficiency, and the prevention of DVT. This is a physical therapy/treatment application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system involving compressed air, tubing, and sleeves applied to the limbs. This aligns with a physical therapy device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with in vitro diagnostics.
In summary, the NormaTec PCD is a therapeutic device that applies external pressure to the body, not a diagnostic device that analyzes samples taken from the body.
N/A
Intended Use / Indications for 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:
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
Product codes
JOW
Device Description
The NormaTec 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
1
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
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.
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.
2
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
3
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
4
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
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 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__________________________________________________________________________________________________________________________________________________________