(92 days)
No
The description focuses on mechanical compression and the control of inflation/deflation by a pump system, with no mention of AI or ML.
Yes
The device is intended to treat or prevent a medical condition (deep vein thrombosis and pulmonary embolism) by providing external limb compression, which is a form of therapy.
No
Explanation: The device described is a compression device used to prevent deep vein thrombosis (DVT) by artificially imitating the pumping action of leg muscles to stimulate blood flow. Its purpose is therapeutic and preventative, not diagnostic.
No
The device description explicitly states that the device is a "compression device" which is a physical component (hardware) that attaches to a pump system. The summary also details bench testing related to the physical integrity and performance of the compression sleeves (bladder leak, seal pull, velcro functionality, inflation-deflation time).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: This device provides external limb compression to prevent blood clots. It works on the outside of the body and does not analyze any biological samples.
- Intended Use: The intended use clearly describes a mechanical action on the body to improve blood flow, not a diagnostic test performed on a sample.
The description focuses on the physical mechanism of compression and its effect on blood circulation, which is characteristic of a therapeutic or preventative medical device, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system.
The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
Product codes
JOW
Device Description
Currie Medical Specialties (CMS) ALP reprocessed compression sleeves are compression devices, which when attached to the ALP 501 Pump System, provide intermittent, sequentially gradient pressure to a patients leg/foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf, thigh or foot. The inflation and deflation sequence is predicated by the ALP 501 Pump System controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg/foot, calf, thigh
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)
Bench testing was conducted to ensure that reprocessing did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices (K955853 & K964188).
Bench testing was conducted to demonstrate a bladder leak test where the bladders were pressurized to 3 psi to ensure the bladders did not leak at this pressure and were not affected by reprocessing. A bladder seal pull test was performed, where the bladder seal was pulled apart at > 5 lbs of force to demonstrate the seals were intact and were not affected by reprocessing. A velcro functionality test was performed where bladders were pressurized to 2 psi to determine velcro adhesion remained intact at this pressure and were not affected by reprocessing. Finally, an inflation-deflation time test was performed to demonstrate product integrity remained the same in comparison to the predicate device. This required the devices to be inflated to 40 mm Hg and monitor the pressure over time. The series of data demonstrated that the reprocessing did not affect the performance, or the safety and efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/0 description: The image shows a symbol and some text. The symbol is an eight-pointed star with a circle in the center. The text to the right of the symbol is cut off, but it appears to be the beginning of some words. The text begins with the letters 'CU' and 'M'.
| Section 11: 510(k) Summary | K140092 pg. 1 of 2 | ||
|---|---|---|---|
| Submitters Name and Address: | Currie Medical Specialties, Inc. | ||
| 8758 Hellman Avenue | |||
| Rancho Cucamonga, CA 91730 | |||
| Phone: (909) 912-0900 | |||
| Fax: (909) 944-3030 | APR 16 201 | ||
| FDA Registration Number: | 2023637 | ||
| Contact Person: | Owen J. Bry, Director of Quality Assurance | ||
| Date Summary Prepared: | 12/17/2013 | ||
| Trade or Proprietary Name(s): | Currie Medical Reprocessed ALP° Calf, Thigh and Foot | ||
| Compression Sleeves (all sizes) . | |||
| Common Name: | Compression sleeve limb | ||
| Product Code: | JOW | ||
| Panel: | Cardiovascular | ||
| Regulation Number: | 870.5800 | ||
| Classification: | Class II | ||
| Predicate Device(s): | K955853 - Healthcare Service & Supply Pump ALP 501 System | ||
| K964188 - Healthcare Service & Supply PVA (Pneumatic Venous | |||
| Augmentation) Foot Garment |
Device Description:
Currie Medical Specialties (CMS) ALP reprocessed compression sleeves are compression devices, which when attached to the ALP 501 Pump System, provide intermittent, sequentially gradient pressure to a patients leg/foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf, thigh or foot. The inflation and deflation sequence is predicated by the ALP 501 Pump System controller.
Intended Use:
The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system.
1
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CURRIE
MEDICAL
SPECIALTIES, INC.
This submission is intended for use of the pump at pressure levels of 40 mm Hg.
Indications for Use:
The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
Technological characteristics of the CMS Reprocessed ALP Calf, Thigh and Foot Compression Sleeves: The CMS ALP Reprocessed Calf, Thigh and Foot Compression Sleeves indications for use, fundamental scientific technology, overall design, materials, energy source, mode of operation, performance characteristics are identical and no different than the predicate device.
Summary of Comparison Tests (Non-Clinical Tests):
Bench testing was conducted to ensure that reprocessing did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices (K955853 & K964188).
Bench testing was conducted to demonstrate a bladder leak test where the bladders were pressurized to 3 psi to ensure the bladders did not leak at this pressure and were not affected by reprocessing. A bladder seal pull test was performed, where the bladder seal was pulled apart at > 5 lbs of force to demonstrate the seals were intact and were not affected by reprocessing. A velcro functionality test was performed where bladders were pressurized to 2 psi to determine velcro adhesion remained intact at this pressure and were not affected by reprocessing. Finally, an inflation-deflation time test was performed to demonstrate product integrity remained the same in comparison to the predicate device. This required the devices to be inflated to 40 mm Hg and monitor the pressure over time. The series of data demonstrated that the reprocessing did not affect the performance, or the safety and efficacy of the device.
Biocompatibility
Reprocessing did not affect the biocompatibility of the device.
Conclusion
The Currie Medical Specialties ALP® Reprocessed Calf, Thigh, and Foot Compression Sleeves have demonstrated that they perform as safe and effective as the ALP® non-sterile predicate devices (K955853 & K964188) and are substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2014
Currie Medical Specialties, Inc. Mr. Owen J. Bry Director of Quality Assurance 8758 Hellman Ave Rancho Cucamonga, CA 91730
Re: K140092
Trade/Device Name: Currie Medical Reprocessed ALP® Calf, Thigh and Foot Compression Sleeves (all sizes) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 18, 2014 Received: February 19, 2014
Dear Mr. Bry:
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 I ou may on ontrols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterstion. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I heast be advised that i Dr i issualite of our device complies with other requirements of the Act
3
Page 2 - Mr. Owen J. Bry
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to .
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuc
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| Applicant: | Currie Medical Specialties, Inc. |
|---|---|
| 510(k) Number (if known): | K140092 |
| Device Name: | Currie Medical Reprocessed ALP. Calf, Thigh and Foot Compression Sleeves (all sizes) |
| Indications for Use: |
The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG ·PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-the-Counter | ||
|---|---|---|---|---|
| Per 21 CFR 801.109 |
Bram D. Zuckerman -S
2014.04.16 10:20:46 -04'00'