(307 days)
Kendall Healthcare Product's sterile sleeve/SCD compression system
Not Found
No
The description focuses on mechanical compression and sterilization, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to prevent DVT and PE by increasing blood flow, which are therapeutic interventions.
No
The device is described as a compressible limb sleeve used to increase blood flow and prevent DVT and PE, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a sterile version of a sleeve used for a pump system and is classified as a compressible limb sleeve, indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)". This is a therapeutic and preventative function, not a diagnostic one.
- Device Description: The device is described as a "compressible limb sleeve" that works by "intermittent compression of the muscles in the lower limbs". This is a physical intervention, not a test performed on biological samples.
- Classification: The device is classified under 21 CFR 870.5800 as a "compressible limb sleeve". This classification is for devices used to apply pressure to limbs, not for in vitro diagnostic tests.
- 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 biological samples
- Providing information for the diagnosis, treatment, or prevention of disease based on the analysis of biological samples.
In summary, this device is a therapeutic/preventative device that works through physical compression, not an in vitro diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.
Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)
Product codes
74 JOW
Device Description
This submission is being made for a sterile version of the sleeve used for the Jobst Athrombic Pump System 2500. This product is a Class II device and is classified as a compressible limb sleeve under 21 CFR 870.5800.
The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, lower limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
recumbent patients, Prescription Use
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 Jobst Athrombic Pump System 2500 with the non-sterile sleeves has been on the market since 1994 and has proven to be safe and effective in that time. The sterile version is being offered for situations where sterile product is preferred.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kendall Healthcare Product's sterile sleeve/SCD compression system
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
17410422
JAN 1 3 1998
510(k) Summary of Safety and Effectiveness
This submission is being made for a sterile version of the sleeve used for the Jobst Athrombic Pump System 2500. This product is a Class II device and is classified as a compressible limb sleeve under 21 CFR 870.5800.
The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.
The Jobst Athrombic Pump System 2500 with the non-sterile sleeves has been on the market since 1994 and has proven to be safe and effective in that time. The sterile version is being offered for situations where sterile product is preferred.
Date: March 11, 1997
Prepared by: Angelo R. Pereira Beiersdorf-Jobst. Inc. 5825 Carnegie Boulevard Charlotte, NC 28209 Phone: (704) 551-7178
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible. The profiles are enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
JAN | 3 |998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Angelo R. Pereira Manager, Regulatory Affairs Beiersdorf-Jobst, Inc. 5825 Carnegie Boulevard Charlotte, NC 28209-4633
K970922 Re: Jobst Athrombic Pump/Sleeve Regulatory Class: II (Two) Product Code: 74 JOW Dated: March 28, 1997 March 31, 1997 Received:
Dear Mr. Pereira:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Angelo R. Pereira
This letter will allow you to begin marketing your device as rnio leceer will as a go a emarket 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Calleh Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 2 Or 2
510 (k) Number (if known): _K970922
Device Name: Sterile Sleeve for Jobst Athrombic Pump
Indications for Use:
Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR Over-The-Counter Use __
Optional Format 1-2-96)
DA Singh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 4970922 510(k) Number_