(15 days)
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Not Found
No
The summary describes a pneumatic compression device and does not mention any AI or ML terms, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used for "treatment and management" of medical conditions, which aligns with the definition of a therapeutic device.
No
The device description and intended use state that it is used for the "treatment and management of venous or lymphatic disorder of the limbs," not for diagnosis.
No
The device description explicitly states it is a "sequential gradient compression pneumatic device," which involves hardware components (pneumatic system, compression garments) to function.
Based on the provided information, the GS-128 Gradient Compression System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The device is used for the treatment and management of venous or lymphatic disorders of the limbs. This involves applying physical compression to the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's a pneumatic device applying compression to the limbs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The GS-128 device is a therapeutic device that applies external physical treatment.
N/A
Intended Use / Indications for Use
The GS-128 Gradient Compression System is a sequential gradient compression pneumatic device used for the treatment and management of venous or lymphatic disorder of the limbs.
Indications For Use:
Common Indications Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Venous Insufficiency Stump reduction Hand edema
The Intended Clinical Settings are as follows:
- In-Home Patient Therapy
- Physical Therapy Clinics/Physician's Office
- Hospital Patient Recovery Room Environments
- Hospital Physical Therapy Environments
Product codes
JOW
Device Description
Medmark Technologies, LLC, Compression Pump, Model GS-128
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
limbs
Indicated Patient Age Range
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Intended User / Care Setting
Physical Therapy Clinics/Physician's Office, Hospital Patient Recovery Room Environments, Hospital Physical Therapy Environments, In-Home Patient Therapy
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2005
MedMark Technologies, LLC. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Mecting, PA 19462-1298
Re: K050584 Model GS-128 Sequential Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: March 7, 2005 Received: March 7, 2005
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave te review your we determined the device is substantially equivalent (for the indications forcreneve above and harsure) to legally marketed predicate devices marketed in interstate for use surved in the encrease 1976, the enactment date of the Medical Device Amendments, or to conninered pror to rial 2011-11-11, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetter fore, market the device, subject to the general controls provisions of the Act. The r va may, mereleve, mixins 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 may be subject to sater adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Robert Mosenkis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issumter of a succession of the requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of any Federal Statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 31equirements, and manufacturing practice requirements as set CFK Fart 807), adoling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2) ===================================================================================================================================== This letter will anow you to oegin mailing of substantial equivalence of your device to a legally premarket nothleation: "The PDF Interingssification 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), please If you desire specific at (301) 594-4646. Additionally, for questions on the contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (201) 594-4097. Alloo, predo not more of 97) you may obtain. Other general information on your promatics nontroution - (Act may be obtained from the Division of Small Manufacturers, ItSponsionnies 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,
Divya R. Richter1
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Medmark Technologies, LLC, Compression Pump, Model GS-128
Intended Use:
The GS-128 Gradient Compression System is a sequential gradient compression pneumatic device used for the treatment and management of venous or lymphatic disorder of the limbs.
Indications For Use:
Common Indications Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Venous Insufficiency Stump reduction Hand edema
The Intended Clinical Settings are as follows:
- In-Home Patient Therapy r
- Physical Therapy Clinics/Physician's Office t
- Hospital Patient Recovery Room Environments 风
- Hospital Physical Therapy Environments I
The Intended Patient Population are patients who are diagnosed with the above listed indications.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Education (ODE)
(Posted November 13, 2003)
DURRE P. WICKENS
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K050584
PAGE 1/2 * RCVD AT 2/22/2005 3:52:21 PM [Eastern Standard Time] * SVR:ECRFAX/2 * DN/S:1175 * CSD:2152491029 * DURATION (mm-s):00-52