(182 days)
No
The document describes a reprocessed mechanical device (sequential compression sleeves) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for prophylaxis against deep vein thrombosis or pulmonary embolism by increasing venous return, which is a therapeutic purpose.
No.
The device is intended to increase venous return as a prophylaxis for deep vein thrombosis or pulmonary embolism, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states that the device is sequential compression sleeves and wraps, which are physical hardware components. The submission is for the reprocessing of these physical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "increase venous return from the lower extremities in as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients." This describes a physical intervention on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as "sequential compression sleeves and wraps" that are reprocessed. This further reinforces that it's a physical device applied externally.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
Therefore, this device falls under the category of a therapeutic or prophylactic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Sequential compression sleeves are intended to increase venous return from the lower extremities in as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients.
Sequential compression sleeves are single patient use devices only.
Product codes
JOW
Device Description
AMI intends to market reprocessed sequential compression sleeves and wraps. Reprocessing sequential compression sleeves and wraps is performed by AMI to AMI protocol Number 40009.
"Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). AMI is a "third party reprocessor" and reprocesses used single-used medical devices.
AMI believes that sequential compression sleeves and wraps can be considered "reusable" - by AMI, as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
Sequential compression sleeves and wraps are designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.
AMI intends to reprocess disposable sequential compression sleeves and wraps manufactured by Kendall (sleeves and foot wraps), Huntleigh and Plexipulse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
non ambulatory patients.
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)
Not Found
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).
0
4dven Medical, Inc.
1001 Slaton Hwy. Lubbock, Texas 79404
Tel: (806) 745-7718 Fax: (806) 745-0223
510(k) SUMMARY
Adven Medical, Incorporated Reference: Section 510(k) Notification Reprocessed Used Disposable Sequential Compression Sleeves / Wraps Classification name: Pumps and Sleeves, 21 CFR 870.5800, Product Code: JOW Common/Usual Name: Femoral Compressible Limb Sleeve or Wrap Proprietary Name: Reprocessed Used Disposable Sequential Compression Sleeves / Wraps Establishment Registration Number: 1649663 Classification: Class II.
AMI intends to market reprocessed sequential compression sleeves and wraps. Reprocessing sequential compression sleeves and wraps is performed by AMI to AMI protocol Number 40009.
"Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). AMI is a "third party reprocessor" and reprocesses used single-used medical devices.
AMI believes that sequential compression sleeves and wraps can be considered "reusable" - by AMI, as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use.
Sequential compression sleeves and wraps are designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism.
AMI intends to reprocess disposable sequential compression sleeves and wraps manufactured by Kendall (sleeves and foot wraps), Huntleigh and Plexipulse.
Adven Medical, Inc., reprocessed sequential compression sleeves and wraps are substantially equivalent to sequential compression sleeves and wraps sold new by Kendall under 510K 942664
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is a stylized image of an eagle with three lines extending from its body. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Mr. Mark W. Aldana President Adven Medical, Inc. 1001 Slaton Highway Lubbock, TX 79404
Re: K012675
K012075
Trade Name: Reprocessed Used Disposable Sequential Sleeves/Wraps Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: January 23, 2002 Received: January 24, 2002
Dear Mr. Aldana:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section JTV(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate ferenced above and nave determined the devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regally mancolou power and called in one of the Enderel Food. Drug commerce prior to May 28, 1970, the enaounters with the provisions of the Federal Food, Drug, devices that have been recalised in accerative approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the and Cosment Act (Act) that do not require cappes the general controls provisions of the Act. The You may, therefore, market the dovices, belyer to the one of registration, listing of
general controls provisions of the Act include requirements for annual registration, lis general controls provisions of the Fields. I quited or quibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Poucharding your device in the Federal Register.
2
Page 2 - Mr. Mark W. Aldana
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscribes with other requirements of the Act
that FDA has made a determination that your device onemales . You must that FDA has made a decermination that your arrise by other Federal agencies. You must or any Federal statules and regulations daministered or registration and listing (21 l
comply with all the Act's requirements, including, but not is answise newirements as se comply with all the Act s requirements, me; good manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 001); good management (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maketing your antint equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, n premarket notification. The PDA iniding of substanted by and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFK Part 807.10 for mirro creations on the promotion and advertising of
Compliance at (301) 594-4646. Additionally, for questions on the promotion and advert Compliance at (301) 594-4040. Additionally) 16. quest 400 (594-4639. Also, please note the your device, picase contact the Office of concerner of premarket notifications of the stars of the regulation entitled, "Misoraliding of responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
C/e
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
K012675 510)k) Number:
Reprocessed Sequential Compression Device Device Name:
Indications For Use:
Sequential compression slecves are intended to increase venous return from the lower extemities in Sequential compression sleeves are miended to mercase veneur of the man
as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients.
Scquential compression sleeves are single patient use devices only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012675
Image /page/3/Picture/9 description: The image shows the phrase "Prescription Use (Per 21 CFR 801.109)". There is a symbol that looks like an X over a line next to the phrase. The text is in a simple, sans-serif font and is left-aligned. The image appears to be a label or a marking indicating the intended use of a product.
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Over-The-Counter Use (Optional Format 1-2-96)