(145 days)
None
Not Found
No
The device description explicitly states it is a preamendment, unclassified device (Medicinal Leeches) and there is no mention of AI or ML in the summary.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an adjunct to the healing of graft tissue," which is a therapeutic purpose.
No
The device description indicates that Medicinal Leeches are used as an adjunct to healing by addressing venous congestion and prolonged localized bleeding, which are therapeutic actions, not diagnostic ones. Diagnostic devices are typically used to identify or detect a disease or condition.
No
The device description explicitly states the device is "Medicinal Leeches, a blood sucking aquatic animal," which is a biological entity, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the application of the leeches to the body to address venous congestion and bleeding issues related to graft healing. This is a direct therapeutic application on a living organism.
- Device Description: The description clearly states that Medicinal Leeches are a "blood sucking aquatic animal" used in "various post surgical situations." This describes a biological entity used for a therapeutic purpose, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or laboratory procedures
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Medicinal Leeches do not fit this description. They are used directly on the patient for a therapeutic effect.
N/A
Intended Use / Indications for Use
An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding.
Product codes (comma separated list FDA assigned to the subject device)
NRN
Device Description
Medicinal Leeches (Hirudo Medicinalis)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
None
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
N/A
0
JUN 2 1 2004
510(k) Summary
Date Prepared: January 15, 2004
- Sponsor 1.
- A Sponsor Name Ricarimpex SAS 245 Avenue de Saint Médard 33320 Eysines France Tel: 011 33 5 56 57 84 12 Fax: 011 33 5 56 57 84 14
Contact Name: Ms. Brigitte Latrille, President E-mail: ricarimpex@leeches-medicinalis.com
-
- System Identification
- A. Proprietary Name
Medicinal Leeches
-
B. Common or Usual Product Name
Hirudo Medicinalis -
C. Product Classification
Preamendment Device - Unclassified
3. Predicate Device
None - Medicinal Leeches are a preamendment device which has yet to be classified
1
Medicinal Leeches Device / Substantial Equivalence Information
The application of leeches as an alternative medicinal treatment as opposed to "previous, predicate devices/methods", such as blood letting and amputation is one of histories oldest treatments whose use can be documented as far back as ancient Egypt and was standard medical practice until the mid 1800's.
Over the past decades surgeons have once again begun to use medicinal leeches as a means to restore venous blood circulation following cosmetic and reconstructive surgery.
Since the leeches bite produces a small amount of bleeding which mimics venous circulation in areas of compromised tissue it is of value in healing following plastic and reconstructive surgery. A leech bite produces anticoagulant and vasodilator substances which allow continued bleeding timprove venous circulation even after the animal has been removed from the patient.
Medicinal leeches, a blood sucking aquatic animal living in fresh water and subject to regulation by the U.S. Fish and Wildlife Service, are a preamendment, unclassified device which, by nature of their historical use and documented value in various post surgical situations,
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or shapes, possibly representing people or services provided by the department.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2004
Ms. Brigitte Latrille President Ricarimpex SAS 245 Avenue de Saint Médard 33320 Eysines France
Re: K040187 Trade/Device Name: Medicinal Leeches Regulatory Class: Unclassified Product Code: NRN Dated: May 11, 2004 Received: May 17, 2004
Dear Ms. Latrille:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(t) presidentially equivalent (for the indications referenced above and nave determined ly marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce provide to May 20, 1978, the enational with the provisions of the Federal Food, Drug, devices that have been recalismed in assess asproval of a premarket approval application (PMA). and Costletic Act (Act) that to not require approvise the general controls provisions of the Act. The You may, therefore, mance the device, books of the counter for annual registration, listing of general controls provisions of are tice, 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 II your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major research and t may be subject to such additional controller Lineang and oc found in the Cours neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuates of a build complies with other requirements of the Act that IDA has made a decommandir that your lear Federal agencies. You must of any reactal statutes and regulations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as secured CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maxemily of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thu premarket hourication. The FDA midning of backandale in 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), please If you desire specific advice for your ac 110 - 4659. Also, please note the regulation entitled, Conlact the Office of Complanes at (set notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to promance notifical varies and responsibilities under the Act from the Division of Small other gelleral information on your response in its toll-free number (800) 638-2041 or Manufacturers, micenational and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Medicinal Leeches (Hirudo Medicinalis)
Indications For Use An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Muraine C. Thorst
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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