(69 days)
The Scholten Novatome™ is a surgical device used to perform endomyocardial biopsies.
The Scholten Surgical Instruments, Inc. Novatome is a manually operated hand held surgical instrument designed to remove biopsy samples from the right or left ventricle of the Human Heart via percutaneous venous or arterial access. Specifically via the internal Jugular or subclavian veins or the femoral artery. The device consists of three main parts. The cutting jaws, a polymer coated flexible shaft, and an actuating handle. At the distal end of the forceps is a pair of jaws used to obtain the heart tissue samples. At the proximal end of the forceps is the actuation handle used to activate the jaws and steer the device. The device cutting jaws are single action in that one of the jaws is fixed and is attached to the end of the flexible shaft and the other jaw is movable and is attached to a link that is welded to the end of the actuation wire. The single moving jaw, the distance the jaws open, as well as the orientation of the jaw work in combination to control the amount of tissue obtained. The Novatome's actuation handle is made of an advanced high-performance polymer. The jaws, actuation wire, and other mechanical parts are made of stainless steel. The flexible shaft sheath material is Fluoropolymer tubing. The Novatome™ will be available in 9,8,7, and 6 French cutting jaw sizes, with flexible shaft lengths of 50, 70, and 100cm lengths.
The provided text describes the 510(k) summary for the Novatome™ Endomyocardial Biopsy Forceps. This device is seeking substantial equivalence to predicate devices, and the document details the non-clinical tests performed rather than an AI-driven study. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis of the provided information, addressing the relevant sections and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as one would expect for a diagnostic AI device. Instead, it describes "performance tests were conducted in several areas." The "reported device performance" is essentially that the device passed these non-clinical tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional | Tests were conducted and passed. |
| Tensile | Tests were conducted and passed. |
| Simulated Biopsy Yield | Tests were conducted and passed. |
| Cutting Jaw Force Tests | Tests were conducted and passed. |
| Sterilization (if applicable) (Implicit based on comparison to predicate) | Device is pre-packaged and sterilized. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests performed are described as "non clinical test" meaning they likely involved simulated environments or in-vitro testing rather than human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The tests were non-clinical performance tests of a surgical instrument, not an AI diagnostic device requiring expert ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Expert adjudication is not relevant for non-clinical performance tests of a surgical instrument.
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 surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, validation would be against engineering specifications and industry standards for surgical instruments. For example, dimensional tests would be validated against design drawings to ensure it meets specified dimensions, tensile tests against material specifications, and simulated biopsy yield against a measure of tissue acquisition in a controlled environment. The "ground truth" for a surgical device's performance would be its adherence to established engineering and performance benchmarks.
8. The sample size for the training set
Not applicable. This device is a surgical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a surgical instrument, not an AI model.
Summary of the Study Proving Device Meets Criteria:
The document states, "Performance tests were conducted in several areas including, dimensional, tensile, simulated biopsy yield, cutting jaw force tests." It concludes, "The Novatome™ was designed utilizing design control methods and is safe and effective for the application for which it is intended. Based on the comparison of the intended use, the design of the predicate devices, and the results of all testing performed, the proposed Novatome™ shows substantially equivalence to the predicate devices."
The study that "proves" the device meets acceptance criteria consists of these non-clinical performance tests. The specific details of these tests (e.g., number of units tested, exact methodology, detailed results) are not provided in this 510(k) summary but would have been part of the full 510(k) submission. The FDA's letter of October 23, 2007, confirms that based on the provided information, the device was found substantially equivalent to predicate devices, implying these tests were deemed sufficient to demonstrate its safety and effectiveness for its intended use. Clinical studies were explicitly not conducted on the Novatome forceps.
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13
SECTION 5 - SUMMARY
UCT 2 3 2007
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Scholten Surgical Instruments, Inc. 170 Commerce St. #101 Lodi, CA 95240 - USA
510k SUMMARY
Konzosi 510K Number:
Jim Van Andel, Chief Operations Officer Submitter: Scholten Surgical Instruments, Inc. 170 Commerce St. #101 Lodi, CA 95240 - USA Ph: 1-209-365-1393 Fax: 1-209-365-1437
Establishment Registration Number: 2936330
Date Prepared: July 20, 2007
| Trade Name: | Novatome™ Endomyocardial Biopsy Forceps |
|---|---|
| Common Name: | Endomyocardial Biopsy Forceps, Bioptome |
| Classification Name: | device, biopsy, endomyocardial (21 CFR870.4075) |
Predicate Devices:
The Scholten Bioptome by Scholten Surgical Instruments Inc. and the Ultra-CBX™ by Medcanica
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Device Description:
The Scholten Surgical Instruments, Inc. Novatome is a manually operated hand held surgical instrument designed to remove biopsy samples from the right or left ventricle of the Human Heart via percutaneous venous or arterial access. Specifically via the internal Jugular or subclavian veins or the femoral artery.
Device Design:
The device consists of three main parts. The cutting jaws, a polymer coated flexible shaft, and an actuating handle. At the distal end of the forceps is a pair of jaws used to obtain the heart tissue samples. At the proximal end of the forceps is the actuation handle used to activate the jaws and steer the device
The device cutting jaws are single action in that one of the jaws is fixed and is attached to the end of the flexible shaft and the other jaw is movable and is attached to a link that is welded to the end of the actuation wire. The single moving jaw, the distance the jaws open, as well as the orientation of the jaw work in combination to control the amount of tissue obtained. These design characteristics are the identical to the Scholten Surgical Instruments, Inc. Scholten Bioptome.
The Novatome's actuation handle is made of an advanced high-performance polymer. The jaws, actuation wire, and other mechanical parts are made of stainless steel. The flexible shaft sheath material is Fluoropolymer tubing.
Device physical properties:
The Novatome™ will be available in 9,8,7, and 6 French cutting jaw sizes, with flexible shaft lengths of 50, 70, and 100cm lengths. These lengths are standard in the industry for endomyocardial biopsy devices.
Intended Use (Indications for use):
The Scholten Novatome™ is a surgical device used to perform endomyocardial biopsies.
Comparison of technological characteristics:
The Novatome™ is designed with the same characteristics as the predicate devices. It, like the others, is designed for endomyocardial biopsy. The Scholten Surgical Instruments Novatome™ is a single use device as is the Ultra-CBX ™ by Medicanica. The Scholten Surgical Instruments Bioptome is reusable.
Additionally, the Novatome™ and the Scholten Bioptome both share a hemostat type finger ring actuating handle that is at a right angle to the flexible shaft. The Novatome™ actuating handle is constructed of a strong light weight,
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material that is injection molded yielding dimensionally consistent components as opposed to the Scholten Bioptome's stainless steel actuating handle constructed from forged components that are hand assembled and hand finished. The Bioptome and the Novatome actuation handles share virtually identical physical geometry. The Ultra-CBX ™ by Medicanica uses a 3 pullring style actuating handle.
Both the Scholten Bioptome and the Novatome™ share the same cutting head design as well as the same flexible shaft construction
One difference between the Novatome™ and the Scholten Bioptome is the device packaging. The Scholten Bioptome is sold non-sterile and is sterilized by autoclaving at the end user facility. The Novatome and the predicate Ultra-CBX TM by Medicanica are pre-packaged and sterilized
Non clinical test performed for determination of substantial equivalence are as follows:
Performance tests were conducted in several areas including, dimensional, tensile, simulated biopsy yield, cutting jaw force tests.
Discussion of Clinical test Performed:
Clinical studies were not conducted on the Novatome forceps.
Conclusion:
The Novatome™ was designed utilizing design control methods and is safe and effective for the application for which it is intended. Based on the comparison of the intended use, the design of the predicate devices, and the results of all testing performed, the proposed Novatome™ shows substantially equivalence to the predicate devices.
End of Summary
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2007
Scholten Surgical Instruments, Inc. c/o Jim Van Andel Chief Operations Officer 170 Commerce St. #101 Lodi, CA 95240
Re: K072051
Novatome™ Endomyocardial Biopsy Forceps Regulation Number: 21 CFR 870.4075 Regulation Name: Endomyocardial Biopsy Device Regulatory Class: Class II (two) Product Code: DWZ Dated: July 20, 2007 Received: July 31, 2007
Dear Mr. Van Andel:
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.
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Page 2 - Mr. Van Andel
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. 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) 276-0120. 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,
lsse
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 - INDICATION FOR USE
Indications for Use
K072051 510(k) Number (if known):
Device Name: Novatome™ Endomyocardial Biopsy Forceps
Indications for Use: The Scholten Novatome™ is a surgical device used to perform endomyocardial biopsies.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use . (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular Devices
Indications for Use Page 1 of 1
510(k) Number K072051
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§ 870.4075 Endomyocardial biopsy device.
(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).