(48 days)
The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
The Microline Electrosurgical Cautery Probes are a line of non-sterile, reusable 3 mm and 5 mm diameter instruments used to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
The provided text is a 510(k) summary for a medical device (Electrosurgical Cautery Probes). It focuses on establishing substantial equivalence to a predicate device rather than presenting extensive performance studies or acceptance criteria for the new device.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in the provided text.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document primarily focuses on establishing substantial equivalence based on device description and comparison to a predicate, not on specific performance criteria or a study demonstrating meeting those criteria.
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. No specific test set or study data is presented.
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)
This information is not provided in the document. No ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No test set or adjudication method is described.
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
This information is not provided in the document. An MRMC study is not mentioned, and AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. As this is an electrosurgical probe, it's a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No ground truth is discussed in the context of device performance testing.
8. The sample size for the training set
This information is not provided in the document. No training set is mentioned as this is a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not provided in the document. No training set or ground truth establishment for it is discussed.
Summary of available information relevant to "proving the device meets acceptance criteria":
The document primarily states that the Microline Electrosurgical Cautery Probes are "substantially equivalent" to the Olsen Electrosurgical reusable laparoscopic electrodes (K913108). This is the core "proof" presented in a 510(k) submission, meaning that the new device is as safe and effective as a legally marketed predicate device.
Specifically:
- Substantial Equivalence Statement: "The Microline Electrosurgical Cautery Probes are substantially equivalent to the Olsen Electrosurgical reusable lapasocopic electrodes (K913108)."
- Basis for Equivalence: "Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Microline Electrosurgical Cautery Probes relative to its predicate."
- Indications For Use: The new device shares the same intended use: "to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula."
In essence, the "acceptance criteria" here are met by demonstrating that the device is fundamentally similar in function, materials, and safety/effectiveness profile to a previously approved device. The "study" proving this is the detailed comparison and justification presented in the 510(k) submission itself, stating that any differences do not impact safety or effectiveness.
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MAY 20 1998
10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
- A. Submittor Information
Microline. Inc. 100 cummings Center Suite 350-G Beverly, MA 01915
(508) 922-9810 Telephone: Contact Person: Mr. Huges de Laforcade President
March 31, 1998 Date Prepared:
- B. Device Identification
Common/Usual Name: Proprietary Name:
Electrosurgical Cautery Probes Not Yet Determined
- C. Identification of Predicate Device(s)
The Microline Electrosurgical Cautery Probes are substantially equivalent to those offered by Olsen Electrosurgical Inc. (K913108) previously cleared and currently marketed.
D. Device Description
The Microline Electrosurgical Cautery Probes are a line of non-sterile, reusable 3 mm and 5 mm diameter instruments used to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
ند Substantial Equivalence
The Microline Electrosurgical Cautery Probes are substantially equivalent to the Olsen Electrosurgical reusable lapasocopic electrodes (K913108). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Microline Electrosurgical Cautery Probes relative to its predicate.
The Microline Electrosurgical Cautery Probes are intended to delivery energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
10
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- Premarket Notification: Truthful and Accurate Statement
Premarket Notification
Truthful and Accurate Statement (As required by 21 CFR 807.87(j))
I certify that, in my capacity as President of Microline, Inc., I believe to the best of my knowledge, that all data and information submitted in the Premarket Notification are truthful and accurate, and that no material fact has been omitted.
H del forado
Signature
Hughes de Laforcade
March 31, 1998
Date
'981188
Premarket Notification Number
1
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Image /page/2/Picture/2 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 coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Microline, Incorporated ·C/O Ms. Jacqueline E. Masse Senior Consultant Interactive Consulting 70 Walnut Street Wellesley, Massachusetts 02181
Re: K981188 Microline Electrosurgical Cautery Probes Trade Name: Regulatory Class: II Product Code: GEI Dated: March 31, 1998 Received: April 2, 1998
Dear Ms. Masse:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with . the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Frod and Drug Administration (FDA) will verify such assimptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Masse
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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(Optional Format 1-2-96)
510(k) Number (if known):
Device Name: Electrosurgical Cautery Probes
Indications For Use:
The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
(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 Devices K981108
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.