(146 days)
Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.
The Hepatostat Set® is an absorbable compression device which allows to perform any type of hepatic resection, large or small, without any significant bleeding. It is made of four pre-perforated absorbable strips. These strips are connected together by twenty Safil® polyfilament ligatures introduced through the liver by a special tubular needle holder. Each suture is terminated by a stainless steel dart and already inserted into a stainless steel tubular needle holder, fitted to the liver thickness. Two clamps enable to bring together two strips.
The provided text describes a 510(k) premarket notification for the "Hepatostat" device, which is an absorbable compression system. The submission expands the intended use of a previously cleared device (K061796).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide specific quantitative acceptance criteria (e.g., success rates, hemostasis time limits) or detailed reported device performance metrics from a clinical study in a table format.
The closest statement to device performance is:
- "Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use."
This is a general statement of equivalence and safety/efficacy rather than specific metrics against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only mentions "Animal testing has been conducted to demonstrate the safety and efficacy for use in splenic and nephric resection." It does not provide the number of animals or specific cases.
- Data Provenance: Animal testing. The country of origin is not specified, but the applicant is Vygon Corporation in the USA. The testing would be considered prospective as it was conducted to support the expanded indication.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The ground truth was established through animal testing, which would involve direct observation of hemostasis and tissue response, likely by veterinary surgeons or animal researchers, rather than human expert interpretation of images or clinical outcomes in humans.
4. Adjudication Method for the Test Set:
- Not applicable. As the ground truth was established through direct observation in animal studies, an adjudication method for human expert review is not relevant.
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:
- No, an MRMC comparative effectiveness study was not done. The device described is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, questions regarding human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was not done. As stated above, this is a physical surgical device, not an algorithm.
7. The Type of Ground Truth Used:
- The ground truth used was direct observation of hemostasis and tissue response in animal studies. This is a form of outcomes data in an animal model.
8. The Sample Size for the Training Set:
- Not applicable. The document describes animal testing done for performance demonstration to support regulatory submission, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no machine learning model training is described.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria, as described in the document, is animal testing.
- Purpose: To demonstrate the safety and efficacy of the Hepatostat for use in splenic and nephric resection.
- Methodology (implied): Direct surgical application of the Hepatostat device in animals undergoing splenic and nephric resections. Observation of hemostasis achievement and potentially post-operative recovery and tissue resorption.
- Results (stated generally): "Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use..."
The document suggests that the acceptance criterion for this animal testing was simply to demonstrate safety and efficacy and substantial equivalence to the previously cleared Hepatostat (K061796) for the expanded indications. Specific quantitative acceptance criteria or detailed results of the animal study are not provided in this 510(k) summary.
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MAY - 6 2008
VYGON CORPORA 2495 General Armistead Avenue Norristown, PA 19403-3685
(800) 544-490 (610) 630-3350 Fax (610) 630-3835 http://www.vygonusa.com
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)
Date of Preparation: November 29, 2007
Courtney Smith, Regulatory Affairs Manager
Applicant:
Vygon Corporation 2495 General Armistead Ave. Norristown, PA 19403
Contact Individual:
Trade Name: Hepatostat
Common Name: Synthetic Absorbable Surgical Suture & Surgical Clamp
610-539-9300 Ext. 110
Regulation Number: 878.4493 & 878.4493
Product Code: GAM & GDJ
Classification Name: Synthetic Absorbable Surgical Suture & Surgical Clamp
Classification: Class II
Predicate Device Name: Hepatostat (K061796)
Device Description:
The Hepatostat Set® is an absorbable compression device which allows to perform any type of hepatic resection, large or small, without any significant bleeding. It is made of four pre-perforated absorbable strips. These strips are connected together by twenty Safil® polyfilament ligatures introduced through the liver by a special tubular needle holder. Each suture is terminated by a stainless steel dart and already inserted into a stainless steel tubular needle holder, fitted to the liver thickness. Two clamps enable to bring together two strips.
Image /page/0/Picture/18 description: The image shows the word "VYGON" in white letters against a black background. The word is in all capital letters and has a bold, sans-serif font. There is a small triangle above the "V" in "VYGON". The background is a rounded rectangle shape.
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Intended Use: Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen It is designed to provide compressive injuries. hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.
- Technology Characteristics: The Hepatostat in this submission is identical to the Hepatostat (K061796). Vygon is resubmitting of premarket notification due to an expanded indication.
Summary of Design Control Activities: Animal testing has been conducted to demonstrate the safety and efficacy for use in splenic and nephric resection.
Conclusion: Performance testing demonstrates that the Hepatostat is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use.
Courtney Smith May 5, 2008.
Courtney Smith Regulatory Affairs Manager
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2008
Vygon Corporation % Ms. Courtney Smith 2495 General Armistead Avenue Norristown, Pennsylvania 19403-3685
Re: K073493
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: April 11, 2008 Received: April 14, 2008
Dear Ms. Smith:
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.
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Page 2 - Ms. Courtney Smith
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K073493
Device Name: Hepatostat
Indications for Use:
Hepatostat Set is an absorbable compression system acting as a tourniquet on the hepatic, splenic and nephric tissue. It is used to achieve hemostasis in hepatic, splenic, and nephric resections. It can also be used for traumatic liver, kidney and spleen injuries. It is designed to provide compressive hemostasis to the wound site, and resorb naturally over time after hemostasis has been achieved.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Division Sign-Off
Division of General Restorative, and Neurological Devices
| 510(k) Number | K073493 |
|---|---|
| --------------- | --------- |
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§ 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.