(152 days)
Not Found
No
The device description is for a biological organism (a leech) and there is no mention of any computational or algorithmic components.
Yes
The "Intended Use / Indications for Use" section explicitly states that leeches "may be used to alleviate the problem of venous congestion," indicating a therapeutic purpose. Additionally, the presence of a predicate device (K040187 - Medicinal Leeches) further supports its classification as a therapeutic device.
No
The device, a European Medicinal Leech, is used to alleviate venous congestion by creating prolonged localized bleeding, which is a therapeutic action rather than a diagnostic one.
No
The device description explicitly states the device is a European Medicinal Leech (Hirudo verbana), which is a biological organism and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the leeches being applied to the body to alleviate venous congestion by creating prolonged localized bleeding. This is a direct therapeutic application to a living organism.
- Device Description: The device is described as a living animal (a leech) used for a therapeutic purpose.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents, calibrators, or controls.
The use of leeches as described falls under the category of a medical device used for a therapeutic purpose, not an in vitro diagnostic test. The predicate device listed (K040187 - Medicinal Leeches) further supports this, as medicinal leeches are regulated as medical devices.
N/A
Intended Use / Indications for Use
Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
Product codes
NRN
Device Description
The device is a European Medicinal Leech (Hirudo verbana). It is a greenish segmented worm of the Annelida worm classification. The animal is a bloodsucking animal living in freshwater.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin flaps, skin grafts, or other tissues
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
Not Found
N/A
0
FEB 1 9 2014
BIOPHARM (UK) LTD.
(Suppliers of leecbes since 1812)
Image /page/0/Picture/4 description: The image is a logo with a triangular shape in the center. The triangle is made up of three leaf-like shapes that converge at a central point. The text "THE BITING EDGE OF SCIENCE" is arranged in a circular fashion around the triangular shape. The text is in a sans-serif font and is black.
BIOPHARM (UK) LTD Bryngelen Manor 2 Bryngwili Road Hendy, Carms SA4 OXT Tel : (01792) 885595 FAX : (01792) 882440 sales@biopharm-leeches.com www.biopharm-leeches.com
Amended 510(k) Summary
Date prepared: December 18, 2013
- Sponsor
Biopharm (UK) Ltd. 2 Bryngwili Road Hendy Carmarthenshire SA4 OXT Wales UK
Fax: 011 44 1792 882440 Tel: 011 44 1792 885595 Contact Name: Bethany Sawyer, Manager E-mail: bethanysawyer@biopharm-leeches.com
- System Identification
A. Proprietary Name Medicinal Leeches
B. Common or Usual Product Name European Medicinal Leeches - Hirudo verbana
C. Product Classification Preamendment Device - Unclassified
Description of the Device 3.
The device is a European Medicinal Leech (Hirudo verbana). It is a greenish segmented worm of the Annelida worm classification. The animal is a bloodsucking animal living in freshwater.
Company Reg. No .: 1771079 VAT Number: 484 273 819
1
BIOPHARM (UK) LTD.
(Suppliers of leeches since 1812)
Image /page/1/Picture/2 description: The image shows a logo with a triangular shape in the center. The triangle is composed of three leaf-like shapes joined at a central point. The text "THE BITING EDGE OF SCIENCE" is arranged in a semi-circular fashion around the central triangular shape. The text is in a simple, sans-serif font and is positioned to curve along the bottom edge of the logo.
BIOPHARM (UK) LTD Bryngelen Manor 2 Bryngwili Road Hendy, Carms SA4 OXT Tel : (01792) 885595 FAX : (01792) 882440 sales@biopharm-leeches.com www.biopharm-leeches.com
How the Device Functions- Including Scientific Concepts Which Form the Basis 4. of the Device
The saliva of the leech contains an anticoagulant (Hirudin) which is responsible for the prolonged bleeding which occurs after the leech has detached. This prolonged bleeding is used in instances where blood has become congested.
5. Intended Use of the Device
Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches can be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
6. Conditions the Device Will Be Used to Treat
Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches can be used to alleviate the problem of venous congestion by creating prolonged localized bleeding,
7. Predicate Device
510/k) number: K040187 - Trade name: Medicinal Leeches
-
- Summary of the Characteristics of Our Device Compared to Its Predicate
Our device and its predicate share the same characteristics, they are both European Medicinal Leeches which are segmented worms of Annelida worm classification. The only difference is that our device is scientifically categorized as the species Hirudo verbana (Southern European Medicinal Leeches) and the predicate is classified as Hirudo medicinalis (Northern European Medicinal Leeches).
- Summary of the Characteristics of Our Device Compared to Its Predicate
On 02/24/2010 at the CITES Conference of Parties (CoP 15) it was agreed that the European Medicinal Leech would be divided into two categories (Northern - Hirudo Medicinalis, and the Southern - Hirudo verbana) based on their geographical distribution. Prior to this all European Medicinal Leeches were classified as Hirudo medicinalis. There are no known differences in the activity spectrums of the two European variants. The two medicinal leech species are used as exact equivalents for use in overcoming problems with venous congestion.
Company Reg. No .: 1771079 VAT Number: 484 273 819
2
BIOPHARM (UK) LTD.
(Suppliers of leeches since 1812)
Image /page/2/Picture/2 description: The image shows a logo with a triangular shape at the top and text around the bottom. The triangular shape is stylized and appears to be made of small dots or specks. The text reads "THE BITING EDGE OF SCIENCE" and is arranged in a semi-circular fashion around the bottom of the triangular shape. The logo is black and white and has a somewhat vintage or retro appearance.
BIOPHARM (UK) LTD Bryngelen Manor 2 Bryngwili Road Hendy, Carms SA4 OXT Tel : (01792) 885595 FAX : (01792) 882440 sales@biopharm-leeches.com www.biopharm-leeches.com
9. Packaging Material Used in Leech Transport
Leeches are shipped in a tied cloth bag, and as with Biopharm (UK) Ltd shipments a sterile polyacrylamide gel is used to keep the leeches moist during transit. The cloth bags are then housed in paper cartons with lids. Polystyrene boxes are used as they maintain a lower internal box temperature. Other polystyrene chips are also used to further insulate the shipment and prevent the cartons moving around too much. Ice packs are sometimes used, depending on the weather, to insure that the leeches do not get over heated.
10. Methods by Which "Used" Leeches are Disposed of as Biohazard Material
As in any situation where exposure to human fluids is possible, wear personal protective equipment as mandated by local regulations. Gloves should be worn at all times when handling leeches that have been used on a patient. Any areas touched by the leech should be treated in a manner similar to contamination by human body fluids. Leeches that have been used on a patient can be disposed of by immersing them in a solution of 70% (or higher) alcohol. Leave them in the alcohol for at least 5 minutes. Once the leeches are fully euthanized package and dispose of them according to the regulations set out by your County and State for liquid biohazard waste.
Company Reg. No .: 1771079 VAT Number: 484 273 819
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2014
Biopharm U.K. Ltd. Ms. Bethany Sawyer Bryngelen Manor 2 Bryngwili Road Hendy, Pontarddulais Swansea, United Kingdom SA4 0XT
Re: K132958
Trade/Device Name: Medicinal Leech Regulatory Class: Unclassified Product Code: NRN Dated: January 15, 2014 Received: January 22, 2014
Dear Ms. Sawyer:
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
4
Page 2 - Ms. Bethany Sawyer
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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 Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132958
Device Name: Medicinal Leech
: 彩票 :
Indications For Use: Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
X AND/OR Over-The-Counter Use Prescription Use_ (21 CFR 807Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) Page 1 of
Image /page/5/Picture/7 description: The image shows the name "Jiyoung Dang -S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The text appears to be digitally rendered, with some slight pixelation around the edges of the letters. The name is likely a signature or a heading.