(40 days)
Not Found
No
The device description details a compression sleeve with graduated compression based on knit construction, and there is no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
Yes
The device is described as assisting in limb size maintenance for patients with edema or lymphedema, which indicates a therapeutic purpose. The compression mechanism and its graduated nature further support its role in treating a medical condition.
No
The device description indicates it is a compression sleeve worn on the arm to manage edema or lymphedema, implying a therapeutic rather than diagnostic function. There is no mention of it collecting or analyzing data to determine a medical condition.
No
The device description explicitly states it is a "circular knit construction" sleeve made of "Nylon and Spandex yarns" intended to be worn on the arm. This describes a physical, hardware component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The C.A.L.M. Sleeve is a physical garment worn on the arm. It works by applying compression to the limb.
- Intended Use: The intended use is to assist in limb size maintenance for patients with edema or lymphedema. This is a physical therapy/management approach, not a diagnostic test performed on a sample.
The device description and intended use clearly indicate that this is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm.
Product codes (comma separated list FDA assigned to the subject device)
DWL
Device Description
The C.A.L.M. Sleeve is of circular knit construction, and is constructed from Nylon and Spandex yarns. The sleeve is intended to be worn on the arm, and covers the arm from wrist to 2" below the pivot point of the shoulder. The C.A.L.M. Sleeve is non-sterile, and is not intended to be sterilized in use.
The knit of the sleeve is graduated. The length of yarn knit in gradually increases from the wrist to the upper portion of the sleeve. This results in a sleeve with compression that decreases from the wrist to the upper arm portion of the sleeve.
The C.A.L.M. Sleeve yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm
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)
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.
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
§ 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Alba-Waldensian, Inc. 425 North Gateway Ave. Rockwood. TN 37854 Telephone: (865) 354-5209 Fax: (865) 354-1541 Contact Person: David Bowman, Technical Director Date Prepared: February 15, 2002
APR 0 3 2002
The following is a summary of safety and effectiveness for:
Proprietary Name: albahealth C.A.L.M. Sleeve
Common/Usual name: Gradient Compression Arm Sleeve
Classification Name: Stocking, Medical Support (per 880.5780)
The C.A.L.M. Sleeve is of circular knit construction, and is constructed from Nylon and Spandex yarns. The sleeve is intended to be worn on the arm, and covers the arm from wrist to 2" below the pivot point of the shoulder. The C.A.L.M. Sleeve is non-sterile, and is not intended to be sterilized in use.
The knit of the sleeve is graduated. The length of yarn knit in gradually increases from the wrist to the upper portion of the sleeve. This results in a sleeve with compression that decreases from the wrist to the upper arm portion of the sleeve.
The C.A.L.M. Sleeve yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm. This is the same level of compression claimed for the Jobst Ready-to-Wear Arm Sleeve (510(k) #K991570) and the Juzo Expert Line Compression Arm Sleeve (510(k) # unknown). This gradient compression helps keep fluid from accumulating in the arm in cases of edema and lymphedema of the arm, and assists in maintenance of the size of the limb in patients undergoing treatment for these conditions.
Search of FDA's MAUDE database did not reveal any adverse events associated with compression arm sleeves. Search of the database under product code DWL identified 10 events associated with graduated compression products (such as anti-embolism and support stockings) designed for use on the leg. Summaries of these 10 adverse events are attached.
Also attached are articles documenting the benefits and effectiveness of compression garments in the treatment of edema and lymphedema.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Bowman Technical Director Alba-Waldensian, Incorporated Healthcare Products Division 425 North Gateway Avenue Rockwood, Tennessee 37854
APR 0 3 2002
Re: K020592
Trade/Device Name: Albahealth C.A.L.M. Sleeve, Model 59001 Regulation Number: 880.5780 Regulation Name: Gradient Compression Arm Sleeve Regulatory Class: II Product Code: DWL Dated: February 15, 2002 Received: February 22, 2002
Dear Mr. Bowman:
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.
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
2
Page 2 - Mr. Bowman
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) 594-4618. 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,
Timothy A. Ulatowski
Tir othy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
:
Statement of Indications for Use
Albahealth C.A.L.M. Sleeve - Catalog #59001 Gradient Compression Arm Sleeve
Indications:
To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm.
Patricia Cucente
ivision Sign-Off) ision of Dental, Infection Control, Ceneral Hospital Devices 205 Ale 00 Humber __