(85 days)
Not Found
Not Found
No
The summary describes a pneumatic compression system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the application of controlled pressure to the lower extremities to prevent blood pooling, which is associated with several medical conditions such as venous insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities, and post-thrombotic syndrome. This preventative action to manage or mitigate a disease or condition falls under the definition of a therapeutic device.
No
The device is used for the application of controlled pressure to prevent blood pooling in the lower extremities, which is a therapeutic rather than a diagnostic function. It addresses conditions associated with blood pooling but does not identify or diagnose them.
No
The description explicitly mentions a "Pneumatic Ambulatory Compression System," which implies a physical device that applies pressure. There is no mention of software as the sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply controlled pressure to the lower extremities to prevent blood pooling. This is a physical therapy/treatment application, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly describes a physical intervention.
- Mentions image processing, AI, DNN, or ML: These are often associated with diagnostic devices that analyze data or images. Their absence further supports it not being an IVD.
- Input Imaging Modality: Not applicable to a compression system.
- Anatomical Site: Lower extremities are the site of application, not the source of a diagnostic sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Boehringer Laboratories, Inc. Pneumatic Ambulatory Compression System (PACS™) is indicated for the application of controlled pressure to the lower extremities in order to prevent blood pooling in the lower venous leg. Pooling of blood in the legs is associated with: venous insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities and post-thrombotic syndrome. The PACS™ is to be used on the order of a Physician.
Product codes
DWL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, lower venous leg, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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): 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.
Not Found
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
Not Found
§ 880.5780 Medical support stocking.
(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Mr. Christopher Radl Project Engineer Boehringer Laboratories, Inc. 500 E. Washington St. Norristown, PA 19401
Re: K020538
Trade Name: Boehringer Laboratories Pneumatic Ambulatory Compression System (PACS) Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: Class II (two) Product Code: DWL Dated: February 15, 2002 Received: February 19, 2002
Dear Mr. Radl:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
1
Page 2 - Mr. Christopher Radl
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Nola Tull
onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K020538
Device Name: Boehringer Laboratories Pneumatic Ambulatory Compression System
Indications for use:
The Boehringer Laboratories, Inc. Pneumatic Ambulatory Compression System (PACS™) is indicated for the application of controlled pressure to the lower extremities in order to prevent blood pooling in the lower Pooling of blood in the legs is associated with: venous leg. insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities and post-thrombotic syndrome. The PACS™ is to be used on the order of a Physician.
(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 | K020538 |
|---|---|
| --------------- | --------- |
Prescription Use/ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)