(245 days)
No
The description focuses on the mechanical function of sequential compression and does not mention any AI/ML components or capabilities.
Yes
The device is designed to "increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism," which are therapeutic aims addressing existing or potential medical conditions.
No
The device is described as a sequential compression sleeve designed to increase venous blood flow to prevent deep vein thrombosis and pulmonary embolism, not to diagnose a condition.
No
The device description explicitly mentions "inflatable air bladders and tubing" and a "compressible sleeve," which are physical hardware components. The summary also describes "comparative bench testing" of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The sequential compression sleeve described is a mechanical device that applies external pressure to the lower limbs to improve blood flow. It does not analyze biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use is to help prevent deep vein thrombosis and pulmonary embolism by increasing venous blood flow, not to diagnose these conditions.
Therefore, this device falls under the category of a therapeutic or preventative medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.
Product codes
JOW
Device Description
The compressible sleeve is a garment used for compressing patient's lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs
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
Comparative bench testing of new Kendall SCD Sequential Compression Device to reprocessed Kendall SCD Sequential Compression Devices was conducted at Medical Device Services, Inc. The data indicates no significant difference in functional and safety characteristics between new and reprocessed devices.
Key Metrics
Not Found
Predicate Device(s)
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
K012979 - response to questions from FDA dated November 16, 2001 510(k) Notification for Compressible Limb Sleeve
510(k) Summary
| 1. | Submitter: | Medical Device Services, Inc. (MDS)
144 West Bringham Road, Building E
St. George, UT 84790
Tel: 435-652-3073
Fax: 435-652-3087 |
|----|------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Ron Fames President |
- i Medical Device Services, Inc.
- August 31, 2001 3. Date prepared:
- Sleeve, Limb, Compressible Device trade name: র্বা
Compressible Sleeve Common name:
Kendall Model 6325 SCD Sequential Compression System 5. Predicate device: K942664
The compressible sleeve is a garment used for compressing patient's 6. Description: lower limbs by inflation with air to aid the blood flow back towards the heart to prevent deep vein thrombosis (DVT) in patients at risk. The inflatable sleeve consists of inflatable air bladders and tubing, and are connected to the OEM equipment using specific connector(s). The MDS reprocessed sleeve pair is cleaned, inspected and sterilized in sealed individual pouches and returned to the originating hospital.
7. Intended Use:
The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.
-
- Technological comparison to predicate device:
The technological characteristics of the reprocessed sleeves are substantially equivalent (in materials, design, and intended use) to the sleeves as originally distributed.
- Technological comparison to predicate device:
ல். Noncritical test summary:
Comparative bench testing of new Kendall SCD Sequential Compression Device to reprocessed Kendall SCD Sequential Compression Devices was conducted at Medical Device Services, Inc. The data indicates no significant difference in functional and safety characteristics between new and reprocessed devices.
-
- Conclusion: The reprocessed Kendall SCD is substantially equivalent to the legally marketed predicate device.
Note: The 510(k) Summary has been modified.
- Conclusion: The reprocessed Kendall SCD is substantially equivalent to the legally marketed predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Public Health Service
MAY 0 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ron Eames President Medical Devices Services, Inc. 144 West Bringham Road, Building E St. George, UT 84790
Re: K012979
Trade Name: Medical Devices Services Reprocessed Compressible Lim Sleeve Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: March 20, 2002 Received: March 21, 2002
Dear Mr. Eames:
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 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.
2
Page 2 - Mr. Ron Eames
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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.
D. D. Tillman, Ph.D.
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
(As required by ODE for all 510(k) received after Jan. 1, 1996.)
510(k) Number:
Device Name:
Compressible limb sleeve
Indications For Use:
The sequential compression sleeve is designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.
(Do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012979
Prescription Use
(Per 21 CFR 801.109) ℵ
or
Over-The-Counter Use