(100 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Kendall Model 7325 SCD Response™ Compression System.
Key Finding: The provided document states that no clinical test results were submitted in support of this premarket notification submission. Therefore, detailed information on acceptance criteria and a study proving the device meets those criteria from a clinical perspective is not available within this document. The submission relies solely on non-clinical comparative testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study demonstrating meeting acceptance criteria was performed, this table will reflect the non-clinical comparative testing conclusions.
| Acceptance Criteria Category | Specific Criteria (Inferred from Non-Clinical Tests) | Reported Device Performance (Summary of Non-Clinical Test Conclusions) |
|---|---|---|
| Functional Performance | Similar compression characteristics to predicate device | Similar |
| Similar pressure control to predicate device | Similar | |
| Similar timing sequence (default cycle) to predicate device | Similar | |
| Operational Performance | Similar operating alarms to predicate device | Similar |
| Similar sleeve compatibility to predicate device | Similar | |
| Similar safety characteristics to predicate device | Similar | |
| Software Performance | Software testing indicated similar performance to predicate device | Similar |
Note: The primary acceptance criterion for this 510(k) submission was "substantial equivalence" to the predicate Kendall SCD Sequel™ Compression System based on these non-clinical performance characteristics. The new feature of detecting venous refill time and adjusting the decompression cycle was considered a "significant change" but its clinical efficacy in reducing DVT was not (or not yet) proven through clinical trials for this submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for a clinical test set, as no clinical tests were performed. For non-clinical bench testing, the sample size is not specified in the document.
- Data Provenance: Not applicable for clinical data. For non-clinical bench testing, the data origin would be the Kendall Company's testing facilities, likely in the USA. The document does not specify a country of origin for the data.
- Retrospective or Prospective: Not applicable, as no clinical tests were performed. Non-clinical bench testing would be considered prospective for the specific tests conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as no clinical tests were performed and thus no "ground truth" for patient outcomes was established by experts in the context of this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no clinical tests were performed requiring adjudication of patient outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is relevant for imaging devices where multiple readers interpret cases. The Kendall SCD Response™ Compression System is a therapeutic medical device, not an imaging device, and no clinical studies were performed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Standalone Study Done: Yes, in a sense, as the non-clinical bench testing evaluated the device's intrinsic mechanical and software performance characteristics in isolation (i.e., without a human patient or a human operator actively "in the loop" making diagnostic/treatment decisions based on its output in a clinical setting). The device's new adaptive feature (detecting venous refill time) was part of this standalone evaluation to demonstrate its functionality and comparability to the predicate device.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" was established by comparing the device's performance to the known specifications and performance characteristics of the legally marketed predicate device (Kendall SCD Sequel™ Compression System), and against internal engineering and safety standards. This is a form of design verification and validation against a predicate's performance.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML-based diagnostic system that typically requires a "training set" in the conventional sense. Its function is based on pre-programmed algorithms and mechanical processes. If the "venous refill time detection" uses an algorithm that was developed based on data, that development process is not detailed here, and it would be more akin to algorithm development data rather than a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there was no specified training set for an AI/ML model. The device's operational parameters would have been developed and validated through engineering design, prototyping, and bench testing, with the "ground truth" being the desired mechanical and functional specifications.
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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.
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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.
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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
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Attachment 2
| Indications for Use Statement | ||
|---|---|---|
| 510(k)Number | K99 2079 | |
| Device Name | Kendall Model 7325 SCD Response™ Compression System | |
| Indications forUse | The SCD RESPONSE Compression System is designed to applysequential compression to the lower limbs to help prevent deepvein 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 _____________
§ 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).