← Product Code [NRN](/productcode/NRN) · K140907

# LEECH, MEDICINAL (K140907)

_Carolina Biological Supply Co. · NRN · Aug 7, 2015 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K140907

## Device Facts

- **Applicant:** Carolina Biological Supply Co.
- **Product Code:** [NRN](/productcode/NRN.md)
- **Decision Date:** Aug 7, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Indications for Use

Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.

## Device Story

Medicinal leeches (Hirudo verbana or Hirudo medicinalis) are laboratory-raised annelids used to treat venous congestion in compromised tissue (e.g., skin flaps, grafts, reattachments). Applied by clinicians to the patient's skin, the leech attaches via suckers to obtain a blood meal. The feeding process induces prolonged localized bleeding (up to 150 mL over 10+ hours), which relieves venous congestion and promotes healing. The device is a biological organism, not a mechanical or electronic system. Clinical benefit is derived from the sustained post-bite bleeding rather than the initial blood removal. Used in clinical settings; requires proper storage (refrigerated) and disposal (isopropyl alcohol immersion) to manage biological waste.

## Clinical Evidence

No clinical data provided. Substantial equivalence is based on the biological identity of the leeches to previously cleared predicate devices.

## Technological Characteristics

Biological device (Hirudo verbana or Hirudo medicinalis). Cylindrical, segmented annelid with head and caudal suckers. No energy source, software, or electronic components. Storage requires 5-10°C environment. Disposal via 70% isopropyl alcohol.

## Regulatory 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)

## Predicate Devices

- Medicinal Leeches (Hirudo Medicinalis) ([K040187](/device/K040187.md))
- European Medicinal Leeches (Hirudo Verbena) ([K132958](/device/K132958.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure with three faces in profile, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2015

Carolina Biological Supply Company Mr. Keith E. Barker Manager, Product Safety and Compliance 2700 York Road Burlington, North Carolina 27215

Re: K140907

Trade/Device Name: Medicinal Leech Regulatory Class: Unclassified Product Code: NRN Dated: July 7, 2015 Received: July 8, 2015

Dear Mr. Barker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K140907

Device Name Medicinal Leech

Indications for Use (Describe)

Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "CAROLINA" in large, bold, black letters. The "O" in Carolina has a symbol in the middle of it. Below the word "CAROLINA" is the phrase "World-Class Support for Science & Math".

# 510(k) SUMMARY

August 6, 2015

Owner

Carolina Biological Supply Company 2700 York Road Burlington NC 27215 USA

| Telephone: | 336-584-0381                                         |
|------------|------------------------------------------------------|
| Fax:       | 336-538-6285                                         |
| Contact:   | Keith Barker, Manager, Product Safety and Compliance |
| E-mail:    | keith.barker@carolina.com                            |

# Device

| Trade Name:                  | Medicinal Leech                                     |
|------------------------------|-----------------------------------------------------|
| Common and Scientific Names: | European Medicinal Leech, <i>Hirudo verbana</i>     |
| Alternatively:               | European Medicinal Leech, <i>Hirudo medicinalis</i> |
| Product Classification:      | Unclassified                                        |

# Equivalent Legally Marketed Product

| 510(K)  | MANUFACTURER      | PRODUCT                                              | DATE     |
|---------|-------------------|------------------------------------------------------|----------|
| K040187 | Ricarimpex SAS    | Medicinal Leeches ( <i>Hirudo Medicinalis</i> )      | 06-21-04 |
| K132958 | Biopharm (UK) Ltd | European Medicinal Leeches ( <i>Hirudo Verbena</i> ) | 02-19-14 |

# Product Description

The Medicinal Leech is a laboratory-raised bloodsucking annelid (segmented worm) that inhabits fresh water. The leech has a cylindrical body, is slightly flattened, and has around 32 segments. It has a disc-shaped sucker at the head end and a tail sucker at the caudal end.

# Product Function

When the leech attaches to the patient's skin to obtain a blood meal, it typically results in prolonged localized bleeding which can help alleviate the problem of venous congestion.

# Indications for Use

Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.

# S-1

### Carolina Biological Supply Company

2700 York Road ● Burlington NC 27215-3398 ● Phone 336.584.0381 ●Fax 800.222.7112 ● www.carolina.com

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Carolina Biological Supply Company. The logo consists of the word "CAROLINA" in large, bold, black letters, with a stylized image of a Carolina lily in the center of the word. Below the logo, in smaller letters, is the phrase "World-Class Support for Science & Math."

# Summary of the Characteristics of Device Compared to Predicates

Carolina Biological Supply Company (Carolina) will normally obtain and offer medicinal leeches that are identical to those approved under K132958, with scientific name Hirudo verbana. If necessary, Carolina may obtain (from a registered source with an approved and registered device) and offer medicinal leeches with scientific name Hirudo medicinalis, as are approved under K040187. Carolina's product is identical to predicate devices.

# Therapeutic Benefits

The major therapeutic benefits of leech application are not derived from the average 5 mL of blood removed during biting (although this may provide immediate, dramatic relief at first), but from the successive release of up to 150 mL of blood for 10 or more hours following the bite.

# Facilities and Handling

Leeches are held in a dedicated, sanitized refrigerated cold room in containers that were initially sanitized by the leech supplier. When reapportioning the leeches is necessary, several controls are in place to avoid contamination. These controls are periodic well water testing for chemical and biological contaminants, careful sanitization of new containers and all leech-handling utensils, limited access to the cold room, use of gloves, and periodic sanitation procedures of all surfaces with bleach.

# Packaging and Transport

Repackaging is done just prior to shipment. Leeches are packed into cloth bags with a sterile polyacrylamide gel. The bags are tied. The cloth bags are placed in paper containers with lids, and the paper container is placed in a foam cooler inside a corrugated carton. Ice packs, when needed, are placed in the foam cooler, along with sufficient packing foam to secure the package contents. Foam package is closed, instruction manual is placed on top, and the corrugated carton is sealed.

# Leech Storage

Medicinal Leeches should be stored in a refrigerator or another cool, dark place for ease of maintenance until they are needed. Leeches will survive for weeks, sometimes months, at temperatures in the range of 5-10℃ (as their metabolic activity levels will be low).

# Leech Disposal

Leeches that have been used on a patient can be disposed of by immersing them in a solution of 70% (or higher) isopropyl alcohol. Leave them in the alcohol for at least 5 minutes and then dispose of them in the same manner as any other potentially infectious biological waste.

# S-2

### Carolina Biological Supply Company

2700 York Road ● Burlington NC 27215-3398 ● Phone 336.584.0381 ●Fax 800.222.7112 ● www.carolina.com

---

**Source:** [https://fda.innolitics.com/device/K140907](https://fda.innolitics.com/device/K140907)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com