(34 days)
Not Found
No
The device description and performance studies focus on mechanical pressure application and fabric properties, with no mention of AI/ML terms or functionalities.
Yes
The device is described as managing lymphedema, other edematous conditions, phlebitis, and vascular malformations, all of which are considered therapeutic applications.
No
The device description indicates that the DM Sleeve applies pressure to move interstitial fluid, which is a therapeutic action, not a diagnostic one. Its indicated uses are for managing conditions like lymphedema and phlebitis, implying treatment rather than diagnosis.
No
The device description explicitly states it consists of a fabric sleeve with foam protrusions, indicating it is a physical medical device, not software only.
Based on the provided information, the DM Sleeve™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the DM Sleeve™ is used to apply pressure to the extremities for managing conditions like lymphedema, phlebitis, and vascular malformations. This is a physical therapy/medical device intended for external application to the body.
- Device Description: The description details a fabric sleeve with foam protrusions that applies pressure. This is a mechanical device, not something that analyzes biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed outside of the body to diagnose a condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The DM Sleeve™ does not fit this description.
N/A
Intended Use / Indications for Use
The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of: Lymphedema and other edematous conditions, phlebitis, and vascular malformations.
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
extremities
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
The DM Sleeve™ underwent safety testing to assure that the product retained its size and shape after washing. In all instances, the DM Sleeve™ functioned as intended and the results observed were as expected.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Koz1102
MAY 0 8 2002
510(k) SUMMARY
Dr. Emily Iker's DM Sleeve™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 (202) 637-5794 Phone: Facsimile: (202) 637-5910
Jonathan S. Kahan Contact Person:
April 4, 2002 Date Prepared:
Name of Device and Name/Address of Sponsor
Emily Iker, M.D., A.P.C. 2021 Santa Monica Boulevard Suite 620E Santa Monica, CA 90404 Phone: (310) 829-7472 Facsimile: (310) 829-2282
Common or Usual Name
Compression Sleeve
Classification Name
Medical Support Stocking
Predicate Devices
D.R. Medical Controlled Pressure Garments (K001300), Jobst Elvarex Compression Garments (K963573), and Jobst Ready-To-Wear Arm Sleeves (K991570).
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Intended Use
The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of:
Lymphedema and other edematous conditions, phlebitis, and vascular malformations.
Technological Characteristics and Substantial Equivalence
The DM Sleeve™ is substantially equivalent to its predicates because it has the same intended use and very similar technological characteristics. Both the DM Sleeve™ and its predicates are intended to apply pressure to the extremities to manage lymphedema and other edematous conditions, phlebitis, and vascular malformations.
The DM Sleeve™ has very similar components as its predicate devices and very similar technological characteristics. Like the Jobst Elvarex Compression Garments (K963573), the DM Sleeve™ consists of a cotton and nylon fabric, which is fitted to the extremity. The DM Sleeve™ and the D.R. Medical Controlled Pressure Garments (K001300) apply non-gradient pressure to move interstitial fluid into venous and lymphatic channels. The DM Sleeve™ applies pressure by means of foam protrusions, while the Jobst Ready-To-Wear Arm Sleeves (K991570) use spandex and nylon. However, both devices raise the same issues of safety and effectiveness, and are therefore substantially equivalent.
Performance Data
The DM Sleeve™ underwent safety testing to assure that the product retained its size and shape after washing. In all instances, the DM Sleeve™ functioned as intended and the results observed were as expected.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Emily Iker , M. D., A.P.C C/O Mr. Jonathan S. Kahan Hogan & Hartson, LLP 555 Thirteenth Street Washington, DC 20004
AY 0 8 2002
Re: K021102
Trade/Device Name: DM Sleeve™ Regulation Number: 880.5780 Regulation Name: Regulatory Class: II Product Code: DWL Dated: April 4, 2002 Received: April 4, 2002
Dear Mr. Kahan:
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 of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Kahan
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), 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 I mis letter will and w you to cognizations of substantial equivalence of your device to 310(t) promatited 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 and additionally = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = of its of Compilar over, 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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kozlloz
INDICATIONS FOR USE FORM
510(k) Number (if known):__K
DM Sleeve™ Device Name:
Indications for Use: The DM Sleeve™ is intended to be used to apply pressure to the thous for Ober indicated for use in the management of:
Lymphedema and other edematous conditions, phlebitis, and vascular malformations.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Patricio Cucurella
(Division Sign-Off) (Division Sign-Only)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Division of Devices and General Hospital Bosho2