(100 days)
Not Found
No
The summary describes a microprocessor-controlled pneumatic compression device with a fixed cycle, and there is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is designed to apply sequential compression to the lower limbs to help prevent deep vein thrombosis, which is a medical treatment or prevention for a disease or condition.
No
Explanation: The device is designed to apply sequential compression to the lower limbs to help prevent deep vein thrombosis, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "microprocessor controlled pneumatic compression device" and mentions "compressible limb sleeves," indicating it includes hardware components beyond just 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 sequential compression to the lower limbs to help prevent deep vein thrombosis. This is a physical intervention applied to the body, not a test performed on a sample taken from the body.
- Device Description: The device description details a pneumatic compression system that physically compresses the limbs. This is consistent with a therapeutic or preventative device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SCD RESPONSE Compression System is designed to apply sequential compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.
Product codes
74 JOW
Device Description
The SCD Response™ Compression System is a microprocessor controlled pneumatic compression device which provides intermittent, sequentially graduated pressure to compressible limb sleeves. When the sleeves compress the legs, the veins collapse, forcing the blood to move toward the heart. After compression, the sleeves deflate, allowing the veins to take shape again and fill with blood. The full cycle then repeats again.
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
Nonclinical Tests - Comparative bench testing of the Kendall SCD Response™ Compression System with the predicate Sequel™ device found similar functional and operational performance characteristics. Such characteristics included compression, pressure control, timing sequence (default cycle), operating alarms, sleeve compatibility, safety, and software testing.
Clinical Tests - No clinical test results were submitted in support of this premarket notification submission.
Test Conclusions - Nonclinical test results of the Kendall SCD Response™ Compression System indicated substantial equivalence to the predicate Sequel™ System.
Key Metrics
Not Found
Predicate Device(s)
Kendall SCD Sequel™ 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
SEP 2 9 1999
Attachment 4
510 (k) Summary
Summary
Substantial Equivalence Summary for the Kendall Model 7325 SCD Response® Compression System
In accordance with 21 CFR Part 807.92, this summary is submitted by:
The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date: April 5, 1999
- Contact Person
Paul W. Evans Director, Regulatory Affairs (508) 261-8203
- Name of the Device
Classification Name: Compressible Limb Sleeve Compressible Limb Sleeve Device Common or Usual Name: Kendall SCD Response™ Compression Proprietary Name: System
3. Statement of Substantial Equivalence
The Kendall SCD Response™ Compression System is substantially equivalent to the Kendall SCD Sequel™ Compression System in that the basis of operation for both devices is the inflation of expandable sleeves which in clinical practice are placed around a patient's lower limbs. Inflation of the sleeve is accomplished using air, and a cycle which operates to alternatively inflate and deflate the sleeves at predetermined intervals. The SCD Response™ and the predicate SCD Sequel™ controller are both electrically powered, and are connected to the inflatable sleeves by plastic tubing.
1
The Kendall SCD Response™ Compression System is substantially equivalent in function, operating parameters, and intended use to the commercially available Kendall SCD Sequel™ Compression System. A significant change between the two systems is that the Response™ system provides the traditional compression sequence of the predicate device with the capability of detecting the patient's venous refill time, and adjusts the decompression cycle to match the user refill time. Over time, this will result in less pooling of blood, and reduce further the potential for deep vein thrombosis (DVT).
Description of the Device
The SCD Response™ Compression System is a microprocessor controlled pneumatic compression device which provides intermittent, sequentially graduated pressure to compressible limb sleeves. When the sleeves compress the legs, the veins collapse, forcing the blood to move toward the heart. After compression, the sleeves deflate, allowing the veins to take shape again and fill with blood. The full cycle then repeats again.
Intended Use of the Device 5.
The Kendall SCD Response™ Compression System is designed to apply sequential compression to the lower limbs to help prevent deep vein thrombosis (DVT) in patients at risk.
6. Technological Characteristics
The technological characteristics of the SCD Response™ Compression System, e.g., overall design, materials, energy source, mode of operation, performance characteristics, etc. are similar to the predicate Sequel™ Device.
7. Performance Data
Nonclinical Tests - Comparative bench testing of the Kendall SCD Response™ Compression System with the predicate Sequel™ device found similar functional and operational performance characteristics. Such characteristics included compression, pressure control, timing sequence (default cycle), operating alarms, sleeve compatibility, safety, and software testing.
Clinical Tests - No clinical test results were submitted in support of this premarket notification submission.
Test Conclusions - Nonclinical test results of the Kendall SCD Response™ Compression System indicated substantial equivalence to the predicate Sequel™ System.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1999
Mr. Paul W. Evans Director, Regulatory Affairs Kendall, CO. 15 Hampshire Street Mansfield, MA 02048
K992079 Re : Kendall Model 7325 SCD Response™ Compression System Requlatory Class: II (Two) 74 JOW Product Code: August 13, 1999 Dated: August 16, 1999 Received:
Dear Mr. Evans:
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 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). 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further requlatory action. 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. Paul W. Evans
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Cillechon
Thomas J. Calla Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2
| Indications for Use Statement | ||
|---|---|---|
| 510(k) | ||
| Number | K99 2079 | |
| Device Name | Kendall Model 7325 SCD Response™ Compression System | |
| Indications for | ||
| Use | The SCD RESPONSE Compression System is designed to apply | |
| sequential compression to the lower limbs to help prevent deep | ||
| vein thrombosis in patients at risk. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bkonu Ahaskeu
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K992079
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _____________