(486 days)
Not Found
No
The device description and intended use clearly describe a biological organism (medicinal leech) and do not mention any computational or algorithmic components related to AI or ML.
Yes
The device is used to alleviate impaired venous blood flow and promote healing in tissues, which aligns with the definition of a therapeutic device.
No
The device is used to alleviate venous congestion and delayed healing by creating prolonged localized bleeding, not to diagnose a condition.
No
The device description clearly states it is a "laboratory-raised bloodsucking annelid (segmented worm)", which is a biological organism, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- Device Function: The Medicinal Leech is a living organism applied directly to the patient's body to address impaired venous blood flow. It acts mechanically and biologically on the tissue itself, not by analyzing a specimen derived from the body.
- Intended Use: The intended use is to alleviate venous congestion and promote healing by creating prolonged localized bleeding, which is a therapeutic action performed directly on the patient.
The provided information clearly describes a device used for a therapeutic purpose applied externally to the body, not for analyzing specimens in vitro for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
NRN
Device 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.
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)
Reference Device(s)
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
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.
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Carolina Biological Supply Company
2700 York Road ● Burlington NC 27215-3398 ● Phone 336.584.0381 ●Fax 800.222.7112 ● www.carolina.com