(88 days)
Not Found
No
The description focuses on pneumatic compression and electronic control of valves, with no mention of AI or ML terms or functionalities. The submission is specifically for the compression sleeves, which are passive components.
Yes
The device is used for the prevention of deep vein thrombosis, which is a medical condition, making it a therapeutic device.
No
The device is indicated for the prevention of deep vein thrombosis, not for diagnosing it. It is a therapeutic device that stimulates blood flow.
No
The device description explicitly states it consists of a pump and compression garments, which are hardware components. While the submission focuses on the garments, the overall system is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the device is an "Intermittent Pneumatic Compression (IPC)" system. It works by applying pressure to the legs and feet using compression garments to stimulate blood flow.
- Intended Use: The intended use is for the "prevention of deep vein thrombosis" by physically stimulating blood flow. This is a mechanical action, not an analysis of biological specimens.
The device operates externally on the body and does not involve the analysis of samples taken from the patient. Therefore, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Restep Deep Vein Thrombosis (DVT) System, consists of the Restep pump and compatible leg and foot compression garments. The system is a lightweight, portable, prescriptive pneumatic compression device that helps to stimulate blood flow in the deep veins of the legs through the use of pneumatically controlled single chamber pressure cuffs, actuated by an electronically controlled pump unit and solenoid valves.
Note: Only the compression sleeves (garments) are the subject of this submission, the pump is not included in the scope of this submission.
Ascent Healthcare Solutions' In addition, operation. reprocessing of Compression Sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.
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 and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves. This included the following tests:
- Biocompatibility .
- Validation of reprocessing ●
- Function test(s) ●
Performance testing t demonstrates that Reprocessed Compression Sleeves perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K101087 pg 1 of 2
SECTION 5: 510(k) SUMMARY
、
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | JUL 1 6 2010 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Contact: | Amanda Babcock
Sr. Regulatory Affairs Specialist
480.763.5300 (o)
863.904.2312 (f)
ababcock@ascenths.com | |
| Date of preparation: | April 15, 2010 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Restep Compression
Sleeves
Common or Usual Name: Compression Sleeve
Classification Name: Compressible Limb Sleeve | |
| Predicate Devices
K090308 | 510(k) Title
Restep DVT System | Manufacturer
Stortford Medical LLC |
| Device description: | The Restep Deep Vein Thrombosis (DVT) System, consists of
the Restep pump and compatible leg and foot compression
garments. The system is a lightweight, portable, prescriptive
pneumatic compression device that helps to stimulate blood flow
in the deep veins of the legs through the use of pneumatically
controlled single chamber pressure cuffs, actuated by an
electronically controlled pump unit and solenoid valves. | |
| | Note: Only the compression sleeves (garments) are the subject
of this submission, the pump is not included in the scope of this
submission. | |
| Indications for Use: | Intermittent Pneumatic Compression (IPC) is indicated for use
for the prevention of deep vein thrombosis due to the presence
of risk factors for thrombus formation during orthopedic, trauma,
urologic, neurology, critical care, general medicine, obstetrics,
and general surgery. | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed
Compression Sleeves are identical to the predicate devices.
The mechanism of action of Reprocessed Compression Sleeves
is identical to the predicate devices in that the same standard
mechanical design, size, and materials are utilized. There are
no changes to the claims, intended use, clinical applications,
patient population, performance specifications, or method of | |
.
1
K101087 pg 2 of 2
Ascent Healthcare Solutions' In addition, operation. reprocessing of Compression Sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations.
Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves. This included the following tests:
- Biocompatibility .
- Validation of reprocessing ●
- Function test(s) ●
Performance testing t demonstrates that Reprocessed Compression Sleeves perform as originally intended.
Conclusion: Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Restep Compression Sleeves) are safe, effective, and substantially equivalent to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold line drawing. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA," which is arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
July 1 6 2010
Ms. Amanda Babcock Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044
Re: K101087
Ascent Healthcare Solutions (AHS) Reprocessed Restep Compression Sleeves Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: April 15, 2010 Received: April 19, 2010
Dear Ms. Babcock:
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. 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.
3
Page 2 - Ms. Amanda Babcock
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); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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,
Dona R. Vahner
ABram D. Zuckerman, M.D. - Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Reprocessed Restep Compression Sleeves
Indications For Use:
Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.
Prescription Use AND/OR × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vohmer.
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Kio 1087
5
. Page 4 - Ms. Amanda Babcock
K101087
Applicant: Ascent Healthcare Solutions 10232 S 51st Street Phoenix, AZ 85044 Contact Individual: Amanda Babcock, Senior Regulatory Affairs Specialist Ph: (480)763-5376 Fax: (863)904-2312 Email: ababcock@ascenths.com
Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve
Device Name: Ascent Healthcare Solutions (AHS) Reprocessed Restep Compression Sleeves
| Manufacturer | Models |
|---|---|
| Restep | RCG-10 Calf Garment (up to 22") |
| Restep | RCG-30 Thigh Garment (up to 32") |
| Restep | RCG-60 Bariatric Garment (up to 27") |
| Restep | RCG-210 Foot Garment (universal size) |
Indications for Use (IFU)
Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.