MEDICINAL LEECHES

K040187 · Ricarimpex Sas · NRN · Jun 21, 2004 · SU

Device Facts

• Record ID: K040187
• Device Name: MEDICINAL LEECHES
• Applicant: Ricarimpex Sas
• Product Code: NRN · SU
• Decision Date: Jun 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

Medicinal leeches (Hirudo medicinalis) are live aquatic animals used as a medical device. Applied topically by clinicians in post-surgical settings, the leech attaches to the patient's skin to feed. During feeding, the leech secretes saliva containing anticoagulant and vasodilator substances into the bite site. This biological action induces prolonged localized bleeding, which relieves venous congestion and restores venous circulation in compromised tissue, thereby supporting the healing of grafts. The device is used in clinical settings following cosmetic or reconstructive surgery.

Clinical Evidence

No clinical data provided. The device is a preamendment, unclassified device supported by historical medical practice and documented use in plastic and reconstructive surgery.

Technological Characteristics

Biological device (Hirudo medicinalis). Operates via natural biological secretion of anticoagulants and vasodilators. No electronic, mechanical, or software components.

Indications for Use

Indicated for patients undergoing plastic and reconstructive surgery where venous congestion threatens graft tissue healing.

Regulatory Classification

Identification

The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. The animal is a bloodsucking aquatic animal living in fresh water. The device should be indicated as: "an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding." See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) (FDA-2024-N-5702)

Submission Summary (Full Text)

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JUN 2 1 2004

K040187

510(k) Summary

Date Prepared: January 15, 2004

- Sponsor 1.
- A Sponsor Name Ricarimpex SAS 245 Avenue de Saint Médard 33320 Eysines France Tel: [phone] Fax: [phone]

Contact Name: Ms. Brigitte Latrille, President E-mail: [e-mail]

- 2. 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 [phone] 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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K040187

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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