(145 days)
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.
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.
This 510(k) premarket notification for Medicinal Leeches (Hirudo Medicinalis) primarily establishes substantial equivalence based on the device's historical use and documented value as a "preamendment device" rather than presenting a traditional study with acceptance criteria and performance metrics against a newer, classified predicate.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, training set details) are not applicable or not provided in the given document.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. This submission is for a preamendment device, relying on historical use and documented value rather than specific performance metrics against a classified predicate. | "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." The document highlights their use since ancient Egypt and their re-adoption in modern surgery to restore venous blood circulation, producing anticoagulant and vasodilator substances that allow continued bleeding and improve venous circulation. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not provided. The submission does not describe a "test set" in the conventional sense of evaluating a new device against a specific set of data.
- Data Provenance: The document refers to the historical use of medicinal leeches as far back as ancient Egypt and their revival in modern surgical practice. This suggests a reliance on retrospective, long-standing clinical experience and historical documentation rather than a specific prospective study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The submission focuses on the historical use and established value of leeches, which does not involve establishing ground truth for a discrete test set by a panel of experts in the context of a new device evaluation.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set requiring expert adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/software device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a biological device (medicinal leeches), not an algorithm or software. Its performance is inherently "standalone" in the sense that the leeches act directly, but not in the context of a computational algorithm.
7. The type of ground truth used
- The "ground truth" for the efficacy and safety of medicinal leeches in this context is based on historical clinical use, documented medical practice over centuries, and established physiological effects (anticoagulant and vasodilator properties, prolonged localized bleeding). This is essentially outcomes data and expert consensus accumulated over extended historical periods, rather than a singular, prospectively established ground truth for a specific study.
8. The sample size for the training set
- Not applicable/Not provided. There is no machine learning component to this device, and thus no "training set" in the computational sense. The "training" here refers to centuries of human experience and medical observation.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, there is no computational training set. The effectiveness is derived from historical and ongoing clinical observation and medical understanding of their biological mechanisms.
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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
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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,
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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.
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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
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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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