(149 days)
Not Found
No
The summary describes a physical compression garment made of fabric and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as applying pressure to an extremity for the management of pooling blood and lymphedema, which are therapeutic purposes.
No
Explanation: This device is for management of blood pooling and lymphedema by applying pressure, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is comprised of fabric (nylon and spandex) and is a physical garment, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply pressure to the extremity for managing pooling of blood and lymphedema. This is a physical intervention applied to the body, not a test performed on samples taken from the body.
- Device Description: The device is a garment made of fabric that applies pressure. This is a mechanical device, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. Torbot Vascular Compression Garments are external devices that provide physical support and pressure.
N/A
Intended Use / Indications for Use
Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema.
Product codes (comma separated list FDA assigned to the subject device)
DWL
Device Description
Torbot Vascular Compression Garments, custom and ready-to-wear, help to prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and spandex which is used in the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremity
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)
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.
K925154, K963573, K991570, K001300, K021102, K013852
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
§ 880.5780 Medical support stocking.
(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also 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, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
OCT 1 8 2006
Torbot Group, Inc., Jobskin Division 510(k) Summary
I. General Information on Submitter
| Name: | Torbot Group, Inc., Jobskin Division |
|---|---|
| Address: | 653 Miami Street |
| Toledo, OH 43605 | |
| Telephone: | (419) 724-1475 |
Fax: (419) 724-1476 E-mail: greg.johnson@torbot.com
Name of Contact Person: Greg Johnson
Date Summary Prepared: May 16, 2006
II. General Information on Device
Trade name: Torbot Vascular Compression Garments
Classification Name: Medical Support Stocking
III. Predicate Devices
Torbot Vascular Compression Garments are substantially equivalent to the following devices:
- Jobst Custom Compression Garments K925154 .
- Jobst Elvarex Compression Garments K963573 .
- Jobst Ready-To-Wear Arm Sleeves K991570 .
- D.R. Medical Controlled Pressure Garments K001300 .
- Dr. Emily Iker's DM Sleeve K021102 .
- . Jobst Ready-To-Wear Gauntlet K013852
1
IV. Description of the Device
Torbot Vascular Compression Garments, custom and ready-to-wear, help to prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and spandex which is used in the predicate devices.
V. Intended Use
Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema.
VI. Technological Characteristics of Device Compared to Predicate Device
Compression for the Torbot Vascular Garments, as well as all the predicate devices, is provided by elastic yarns that act circumferentially on the extremity. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic drainage and/or absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema.
Greg Johnson General Manager Torbot Group, Inc., Jobskin Division
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Torbot Group, Incorporated Mr. Greg Johnson General Manager Jobskin Division 653 Miami Street Toledo, Ohio 43605
OCT 1 8 2006
Re: K061411
Trade/Device Name: Torbot Vascular Compression Garment Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: August 14, 2006 Received: August 14, 2006
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (PMA), it may be subject to such additional controls. Existing major regulations offecting 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 Ederal Register.
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Page 2 - Mr. Johnson
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 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) 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Torbot Vascular Compression Garment
Indications For Use: Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema.
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 Evaluation (ODE)
hle for Aow 10/17/2002
ം Anesthesiology, General Hospital on Control, Dental Devices
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