(199 days)
Not Found
Not Found
No
The summary describes a simple mechanical aid for applying compression stockings and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The document indicates that the device is an "accessory to medical support stockings" and an "application aid" for putting them on, rather than providing therapy itself.
No
The device is an aid for applying medical support stockings and does not perform any diagnostic function.
No
The device description explicitly states it is a "lightweight steel frame application aid," indicating it is a physical hardware device, not software.
Based on the provided information, the medi Butler is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- medi Butler's Function: The medi Butler is described as an "accessory to medical support stockings" and an "application aid" for putting on these stockings. It is a physical tool used externally on the body.
- No Specimen Analysis: There is no mention of the medi Butler analyzing any biological specimens or providing diagnostic information about a patient's health.
Therefore, the medi Butler falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The medi Butler is indicated for use as an accessory to medical support stockings to prevent pooling of blood in the legs. The medi Butler aids in the application of medical support stockings to the legs.
Product codes
DWL
Device Description
The Butler is a lightweight steel frame application aid that solves the often difficult problem of applying compression stockings. The application aid is suitable for all compression stocking sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Jobst Stocking Donner
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
2005 DEC 5
MEDIVEN BUTLER 510(K) SUMMARY
I. General Information on Submitter
Name: medi USA L.P. Address: 6481 Franz Warner Parkway Whitsett, NC 27377 Telephone: (336) 449-4440 Fax: (336) 449-4495 Name of Contact Person: Scarlette Foust Date Summary Prepared: October 7, 2005
II. General Information on Device
Trade Name: medi Butler
Classification Name: Application Aid, Accessory to a Medical Support Stocking
III. Predicate Devices
21 C.F.R. § 880.5780(a)
IV. Description of the Device
The Butler is a lightweight steel frame application aid that solves the often difficult problem of applying compression stockings. The application aid is suitable for all compression stocking sizes.
V. Intended Use
The medi Butler is indicated for use as an accessory to medical support stockings to prevent pooling of blood in the legs. The medi Butler aids in the application of medical support stockings to the legs.
VI. Technological Characteristics of Device Compared to Predicate Device
The medi Butler consists of similar construction to other devices that have been used as accessories to medical support stockings. As per the FDA's request, because the Agency does not have a current 510(k) application on file for this class of accessory device, we have provided comparison information for the Jobst Stocking Donner, a Class I 510(k) exempt accessory to medical support stocking for general medical purposes, using welded steel alloy construction that has been painted. The medi Butler's steel alloy composition is designed to enhance the strength of the device.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines extending from its head. The eagle is facing to the right.
Public Health Service
DEC 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medi USA, L.P. C/O Mr. Gary L. Yingling Kirkpatrick & Lockhart Nicholson Graham LLP 1800 Massachusetts Avenue, N.W. Washington, DC 20036
Re: K051324
Trade/Device Name: Med: Butler Regulation Number: 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: November 4, 2005 Received: November 9, 2005
Dear Mr. Yingling:
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.
2
Page 2 - Mr. Yingling
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DA s issuance of a baceaning that your device complies with other requirements mean that ITDA nas maco a deceminations administered by other Federal agencies. of the Act of ally I cucha statutes and reguraments, including, but not limited to: registration You must colliply with an the Act 3 requirements) ; good manufacturing practice and listing (21 CFR Part 807), labeling (21 CFR Pat 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (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) I his letter will anow you to oven mainening your substantial equivalence of your device to a premarket notification. The PDF miaming of cassification 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), If you desire specific advice for your do records at (240) 276-0115. Also, please note the regulation
Venese contact the Office of Compliance at (240) 276-0115. Also, pres entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain official information on the mational and Consumer Assistance at its toll-free Division of Chiasa 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ours
Shin-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
KOS 1324
Indications for Use
510(k) Number: K051324
Device Name: medi Butler
Indications for Use: Prescription
The medi Bulter is indicated for use as an accessory to medical support stockings. The The medi Butler is a lightweight steel frame aid for the application of medical support
medi Butler is a lightweight steel frame aid for the application of medical increase medi Butter is a lightweight stock interior in the for all compression stocking sizes.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
Over-The-Counter Use NO AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
xell For AMW "11/2/6
Anasthesiology, Gen