(24 days)
Not Found
No
The device description and intended use clearly describe a simple elastic bandage with added elements (Germanium or Titanium Oxide) for physical support and relief of discomfort. There is no mention of any computational or data-driven processes that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended to provide relief of minor physical discomforts and support for post-injury impacts, which are therapeutic claims. It also uses a predicate device that is a therapeutic device.
No
The device description and intended use do not mention any function related to identifying, monitoring, or predicting medical conditions or diseases. It is described as providing relief and support, not diagnosis.
No
The device description clearly states it is an "elastic compression bandage" containing physical components (Germanium or Titanium Oxide pellets), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosing, monitoring, or screening for diseases or conditions.
- Device Description and Intended Use: The Petit Silma Elastic Bandage is a physical device applied externally to the body (elbow, knee, wrist) to provide support and relief of minor physical discomforts. It does not involve the analysis of any biological specimens.
The device's function is purely mechanical support and potential therapeutic effects from the embedded elements, which falls under the category of a physical therapy or support device, not an IVD.
N/A
Intended Use / Indications for Use
Petit Silma Elastic Bandage is an elastic bandage to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actions associated with athletic, workplace and at-home activities. The device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.
Product codes (comma separated list FDA assigned to the subject device)
FQM
Device Description
The Petit Silma Elastic Bandage is a simple device to provide relief of minor physical discomforts arising from stress or strain of repetitive actions including athletic, workplace and at-home activities. It consists of an elastic compression bandage, containing the element Germanium in a circular pellet. The product is worn on the injured portion of the body (elbow, knee, wrist) as appropriate. Alternatively, a second version of the the product would contain a Titanium Oxide pellet, instead of Germanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow, knee, wrist
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
§ 880.5075 Elastic bandage.
(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(b)
Classification. Class I (general 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. The device also is 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
MAY - 3 2004
APPENDIX E
510(k) SUMMARY Petit Silma Elastic Bandage Bio-Lipid, Inc.
This 510(k) summary of safety and effectiveness for Petit Silma Elastic Bandage is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Bio-Lipid, Inc. |
|---|---|
| Address: | 7000 SW 97 Avenue |
| Suite 213 | |
| Miami, FL 33173 | |
| Contact Person: | David J. Bloch |
| Regulatory Counsel | |
| Telephone: | (202) 414-9209 (telephone) |
| (202) 414-9209 (fax) | |
| Preparation Date: | March 2004 |
| Device Trade Name: | Petit Silma Elastic Bandage With Germanium/Titanium |
| Oxide | |
| Common Name: | Elastic Bandage or Compression Bandage |
| Classification Name: | Elastic Bandage (see 21 C.F.R. § 880.5075) |
| Product Code: FQM | |
| Predicate Devices: | Comfort Care™ Compression Support With Magnets, 510(k) |
K013239, manufactured by Med Gen, Inc. |
| Device Description: | The Petit Silma Elastic Bandage is a simple device to
provide relief of minor physical discomforts arising from
stress or strain of repetitive actions including athletic,
workplace and at-home activities. It consists of an elastic
compression bandage, containing the element Germanium
in a circular pellet. The product is worn on the injured portion
of the body (elbow, knee, wrist) as appropriate.
Alternatively, a second version of the the product would
contain a Titanium Oxide pellet, instead of Germanium. |
1
| Intended Use: | Petit Silma Elastic Bandage is an elastic bandage to provide
relief of minor physical discomforts that have their origin in
stress and strain of repetitive actions associated with
athletic, workplace and at-home activities. The device
provides support for unprotected vulnerable body parts and
post-injury impact induced by overexertion in self-limiting
physical injuries. |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONCLUSIONS: | Based on the foregoing and other information in this
application, Bio-Lipid, Inc. believes that the Petit Silma
Elastic Bandage is substantially equivalent to its claimed
predicates under conditions of intended use. |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Leda Company Limited C/O Mr. David J. Bloch Regulatory Counsel Reed Smith, L.L.P. 1301 K Street, N.W. Suite 1100-East Tower Washington, D.C. 20005-3373
Re: K040936
Trade/Device Name: Petit Selma Elastic Bandage with Germanium/Titanium Oxide Regulation Number: 880.5075 Regulation Name: Elastic Bandage Regulatory Class: I Product Code: FQM Dated: April 9, 2004 Received: April 9, 2004
Dear Mr. Bloch:
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.
3
Page 2 - Mr. Bloch
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 (OS) 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation 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 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.
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
Enclosure
4
Indications for Use
K040936 510(k) Number (if known):
Device Name: Petit Selma Elastic Bandage with Germanium/Titanium Oxide
Indications For Use:
The Petit Silma Elastic Bandage with Germanium/Titanium Oxide is designed to provide relief of minor physicial discomforts that have their origin in stress and strain of repetitive actions associated with athletic, workplace and at-home activities. The device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arene Ramera for ADW 4/29/04
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040936