(486 days)
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.
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.
This document is a 510(k) summary for a medical device called "Medicinal Leech" (K140907). It outlines the substantial equivalence determination for marketing the device.
Based on the provided text, the device is a Medicinal Leech, classified as Unclassified with product code NRN.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
This document describes a medical device, a Medicinal Leech, which is a biological entity. The FDA's substantial equivalence review for such a device does not typically involve traditional "acceptance criteria" based on quantitative performance metrics like sensitivity, specificity, or accuracy, as would be seen for an AI/software device. Instead, the review focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device.
The "performance" of the medicinal leech is described in terms of its function and therapeutic benefits, rather than specific numerical acceptance criteria.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as described) |
|---|---|
| Safety and Effectiveness (Equivalent to predicates) | The Medicinal Leech (Hirudo verbana or Hirudo medicinalis) is presented as identical to predicate devices (K040187, K132958). Its function is to facilitate prolonged localized bleeding when it attaches to the patient's skin for a blood meal. Therapeutic benefits include alleviating venous congestion and delayed healing, primarily through the release of up to 150 mL of blood over 10 or more hours following the bite. Controls are in place for handling, packaging, and storage to avoid contamination and maintain viability. |
| Indications for Use (Equivalent to predicates) | 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. This is identical to the indications for use of the predicate devices. |
| Product Characteristics (Equivalent to predicates) | The device is a laboratory-raised bloodsucking annelid, cylindrical, slightly flattened, with around 32 segments, and disc-shaped suckers at both ends. It is stated to be identical to the predicate devices in its scientific name (Hirudo verbana or Hirudo medicinalis) and general characteristics. Facilities and handling procedures are described to ensure quality and prevent contamination. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical trials or performance studies with a specific sample size. The FDA review for this device is based on demonstrating substantial equivalence to existing legally marketed predicate devices. This typically involves comparing characteristics, indications for use, and safety/effectiveness profiles rather than presenting de novo clinical study data for acceptance criteria.
Therefore, there is no explicit test set sample size or data provenance described for this 510(k) submission. The "data" provenance would implicitly be from the history of use and the regulatory approvals of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there is no "test set" or ground truth established in the sense of a clinical or image-based diagnostic performance study for this type of device. The ground truth, if one could apply the term, would be the established medical consensus on the therapeutic utility and safety profile of medicinal leeches, which has been accumulated over centuries of use and recognized in prior regulatory approvals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no specific test set requiring adjudication in this regulatory submission.
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 device is a medicinal leech, a biological product, not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI/software performance, which is not relevant to a medicinal leech.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" is implicitly the established safety and effectiveness profile of legally marketed predicate medicinal leech devices, supported by historical medical use and scientific understanding of their physiological effects. This is a form of historical medical consensus and clinical experience, rather than a specific, newly generated type of ground truth data (like pathology or outcomes from a new clinical trial).
The study that proves the device meets the acceptance criteria (Substantial Equivalence):
The "study" here is not an experimental clinical trial, but rather a comparative analysis demonstrating substantial equivalence to predicate devices.
The document states:
- "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."
The listed predicate devices are:
- K040187: Ricarimpex SAS, Medicinal Leeches (Hirudo Medicinalis), Approved 06-21-04
- K132958: Biopharm (UK) Ltd, European Medicinal Leeches (Hirudo Verbena), Approved 02-19-14
Proof of Meeting Acceptance Criteria:
The core of the submission (and the "study" by regulatory standards here) is the assertion and demonstration that the characteristics, indications for use, and operational aspects (facilities, handling, packaging, storage, disposal) of the Carolina Biological Supply Company's Medicinal Leeches are substantially equivalent to those of these two legally marketed predicate devices. By proving they are "identical" in all relevant aspects to already-approved devices, the manufacturer demonstrates they meet the implicit safety and effectiveness "acceptance criteria" established by the predicates.
8. The sample size for the training set
Not applicable. This is not an AI/software device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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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
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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
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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)
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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, Hirudo verbana |
| Alternatively: | European Medicinal Leech, Hirudo medicinalis |
| Product Classification: | Unclassified |
Equivalent Legally Marketed Product
| 510(K) | MANUFACTURER | PRODUCT | DATE |
|---|---|---|---|
| K040187 | Ricarimpex SAS | Medicinal Leeches ( Hirudo Medicinalis ) | 06-21-04 |
| K132958 | Biopharm (UK) Ltd | European Medicinal Leeches ( Hirudo Verbena ) | 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
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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
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