(129 days)
Not Found
No
The summary describes a purely mechanical, absorbable compression device and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is intended to achieve hemostasis and reduce bleeding, which are clearly therapeutic actions.
No
The device description indicates that the Hepatostat Set is a compression system used as a tourniquet to reduce bleeding and achieve hemostasis during hepatic resections or for traumatic liver injuries. Its purpose is therapeutic (hemostasis), not diagnostic.
No
The device description clearly states it is an "absorbable compression device" consisting of "four pre-perforated absorbable strips" and "polyfilament ligatures introduced through the liver with a tubular needle." This describes a physical, implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to apply compression and achieve hemostasis during surgical procedures on the liver.
- Device Description: The description details an absorbable compression device that is sutured into the liver tissue. This is a surgical implant/device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Hepatostat Set does not fit this description.
N/A
Intended Use / Indications for Use
Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.
Product codes (comma separated list FDA assigned to the subject device)
GAM, GDJ
Device Description
The Hepatostat Set is an absorbable compression device which was developed for the purpose of hepatic resection, large or small, without any significant bleeding. It consists of four pre-perforated absorbable strips which are sutured together with Safil polyfilament ligatures introduced through the liver with a tubular needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hepatic tissue / liver
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)
Biocompatibility testing of the material in accordance with ISO 10993-1, including implantation testing at 3, 6, 12 and 15 months demonstrates performance and biocompatibility of the device. In vitro testing demonstrates that the device performance. Sterility testing ensures a sterility assurance level of 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mar-Med Liver Strap (K924223), Vicryl Synthetic Absorbable Surgical Suture (K033746), Safil Synthetic Absorbable Surgical Suture (K031286), MonoSyn Synthetic Absorbable Surgical Suture (K011375)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
Kα61796
page i/2
VYGON CORPORATION
2495 General Armistead Avenue Norristown, PA 19403-3685
(800) 544-4907 (610) 630-3350 Fax (610) 630-3835
510K Premarket Notification Submission Summary of Safety and Efficacy
Date of Preparation: September 22, 2006
NOV - 2 2006
Applicant:
Vygon Corporation 2495 General Armistead Ave. Norristown, PA 19403
878.4493 + 878. 4800
Mar-Med Liver Strap (K924223)
through the liver with a tubular needle.
Contact Individual:
Courtney Smith, Regulatory Affairs Manager 610-539-9300 Ext. 110
Trade Name:
Common Name:
Product Code:
Classification Name:
Classification: Class II
Predicate Device Name:
Device Description:
Vicryl Synthetic Absorbable Surgical Suture (K033746) The Hepatostat Set is an absorbable compression device which was developed for the purpose of hepatic resection, large or small, without any significant bleeding. It consists of four pre-perforated absorbable strips which are sutured together with Safil polyfilament ligatures introduced
Synthetic Absorbable Surgical Suture & Surgical Clamp
Safil Synthetic Absorbable Surgical Suture (K031286) MonoSyn Synthetic Absorbable Surgical Suture (K011375)
Intended Use:
Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.
Vicon
Hepatostat Set
AbSorbable
GAM
Liver Clamp
Name:
Name:
Regulation Number:
Product Code:
Classification Name
C
Predicate Device Names
1
K061796 Page 42
Technology Characteristics: The Absorbable strips and Safile sutures are broken down by bydrolysis, both copolymers degrade into glycolic and lactic acid which are subsequently metabolized and absorbed by the body. Liver hemostasis is fairly rapid (approximately 15 days) and is not impeded by the reabsorption of the strips and sutures. Complete absorption of the sutures occurs between 60 and 60 days.
Summary of Design Control Activities:
Biocompatibility testing of the material in accordance with ISO 10993-1, including implantation testing at 3, 6, 12 and 15 months demonstrates performance and biocompatibility of the device. In vitro testing demonstrates that the device performance. Sterility testing ensures a sterility assurance level of 10-6.
Conclusion:
Biocompatibility and implant testing, performance testing and risk assessment demonstrate that the Hepatostat Set is safe and effective to use, when used in accordance with the supplied instructions for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vygon Corporation % Regulatory Affairs Associates, LLC Mr. Stephen Goldner 30833 Northwestern Highway Suite 121 Farmington Hills, Michigan 48334
NOV - 2 2006
Re: K061796
Trade/Device Name: Hepatostat Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM, GDJ Dated: September 30, 2006 Received: October 3, 2006
Dear Mr. Goldner:
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,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 – Mr. Stephen Goldner
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061796
Device Name: Hepatostat
Indications For Use:
Hepatostat Set is a compression system acting as a tourniquet on the hepatic tissue. It is intended to reduce the risk of bleeding and to achieve hemostasis in hepatic resections (from large to small superficial hepatectomy). It can also be used for traumatic liver injuries.
Prescription Use X X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
R. Rmz
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division of General Restorative. and Neurological Devices
510(k) Number L061796