(113 days)
Not Found
No
The document describes a mechanical compression system and does not mention any AI or ML components or functionalities.
Yes
The device's intended use includes preventing DVT, diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time, all of which are therapeutic purposes.
No
The device is described as a compression system intended for therapeutic purposes like preventing DVT, diminishing pain and swelling, and enhancing blood circulation, rather than for diagnosing any condition.
No
The device description explicitly states the system consists of a control unit, inflatable limb sleeves, and conduit tubing, which are all hardware components. The summary focuses on the reprocessing of the physical compression sleeves.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a physical therapy/medical device used externally on the body to prevent DVT, reduce pain and swelling, enhance circulation, and reduce wound healing time. This is a therapeutic and preventative function, not a diagnostic one.
- Device Description: The description details a system of external compression components (control unit, sleeves, tubing). This aligns with a physical medical device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) and provides a physical therapeutic effect.
N/A
Intended Use / Indications for Use
When coupled with an appropriate inflation system. compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with connectors for pump attachment. Only the compression sleeves are reprocessed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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 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.
K060049, K060091, K053316, K051438, K012403, K024087, K024074, K021654, K011192
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
K100909 pg 1 of 2
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | JUL 23 2010 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Contact: | Ramona Kulik
Regulatory Affairs Engineer
480.763.5300 (o)
480.763.2952 (f)
rkulik@ascenths.com | |
| Date of preparation: | March 31, 2010 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression Sleeves
Common or Usual Name: Compression Sleeve
Classification Name: Compressible Limb Sleeve | |
| Predicate Devices
K060049 | 510(k) Title | Reprocessor |
| | Reprocessed Compression Sleeves | Alliance Medical
Corporation |
| K060091 | Reprocessed Compression Sleeves | Alliance Medical
Corporation |
| K053316 | Vanguard Reprocessed
Compression Garments | Vanguard Medical
Concepts |
| K051438 | Vanguard Reprocessed
Compression Garments (Hill-Rom) | Vanguard Medical
Concepts |
| K012403 | Vanguard Reprocessed
Compression Garments | Vanguard Medical
Concepts |
| K024087 | Reprocessed Compression Sleeves | Alliance Medical
Corporation |
| K024074 | Reprocessed Compression Sleeves | Alliance Medical
Corporation |
| K021654 | Reprocessed Compression Sleeves | Alliance Medical
Corporation |
| K011192 | Reprocessed Compression Sleeves | Alliance Medical
Corporation |
،
1
K100909 pg 2 of 2
Indications for Use: When coupled with an appropriate inflation system. compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
Device Description: Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with connectors for pump attachment. Only the compression sleeves are reprocessed.
Technological The design, materials, and intended use of Reprocessed characteristics: 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 operation. In addition, Ascent Healthcare Solutions' 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 demonstrates · that · Reprocessed Compression Sleeves perform as originally intended.
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Compression Sleeves) are safe. effective, and substantially equivalent to the predicate devices as described herein.
Conclusion:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 3 2010
Ms. Ramona Kulik Regulatory Affairs Engineer 10232 South 51st Street Phoenix, AZ 85044
Re: K100909
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: July 9, 2010 Received: July 10, 2010
Dear Ms. Kulik:
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. Isting 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. 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
3
Page 2 - Ms. Ramona Kulik
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/CDRHOffices/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,
una R. L. Auner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 - Ms. Ramona Kulik
K100909
Applicant: Ascent Healthcare Solutions 10232 S 51st Street Phoenix, AZ 85044 Contact Individual: Ramona Kulik, Regulatory Affairs Engineer Ph: (888)888-3433 Fax: (480)763-2952 Email: rkulik@ascenths.com
ट
JUL 2 3 2010
Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve
Device Name: Ascent Healthcare Solutions (AHS) Reprocessed Restep Compression Sleeves
| Manufacturer | Foot | Calf | Thigh |
|---|---|---|---|
| Kendall | 5065, 5075, 5107, | ||
| 5897, 5898, 5046, | |||
| 5048, 5057, 5059 | 5329, 5329-M, 5489, | ||
| 5489-M, 9529, 9789 | 5330, 5330-M, 5345, | ||
| 5345-M, 5480, 5480- | |||
| M, 9530, 9545, 9780 | |||
| Healthcare Services and | |||
| Supply | PVA-1, PVA-2 | ALP-1, ALP-2, ALP- | |
| 2XL | ALP-3, ALP-3(S), | ||
| ALP-4 | |||
| Hill-Rom | P3808 | P3801, P3801-L, | |
| P3802, P3802-L, | |||
| P3803, P3803-L, | |||
| P3804, P3804-L, | |||
| P3841, P3842, P3843 | P3805, P3805-L, | ||
| P3806, P3806-L, | |||
| P3807, P3807-L | |||
| Huntleigh Healthcare | FG-100, FG-100(2), | ||
| FG-100R, FG-100R(2), | |||
| FG-200, FG-200(2), | |||
| FG-200R, FG-200R(2) | DVT-10, DVT-10(S), | ||
| DVT-20, DVT-60, | |||
| L501-M | DVT-30, DVT-30(S), | ||
| DVT-40, | |||
| Compression Therapy | |||
| Concepts | VP520, VP520L, | VP501L, VP501M, | |
| VP501P, | VP530B, VP530L, | ||
| VP530M | |||
| Kinetic Concepts Inc | 235340 | 112453 | 112452 |
| Microtek | V3012, V3014, V3022, V3026, V3030 | ||
| Aircast Inc. | 3016, 3016-5, 3016-PL | 3010, 3010-5, 3010- | |
| PL, 3012, 3012-5, | |||
| 3012-PL, | 3015, 3015-5, 3015-PL |
Indications for Use (IFU)
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
ﻤﺸﺎﺭ
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ¿¡ 00 90 9
Device Name: Reprocessed Compression Sleeves
Indications For Use:
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
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)
smna 12. vi. Annes
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_King 969