(90 days)
The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radio frequency current and saline for blunt dissection, hemostation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
TissueLink Solid Cylinder monopolar device
The provided document is a 510(k) Premarket Submission for a medical device (TissueLink Solid Cylinder monopolar device) and its corresponding FDA clearance letter. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through performance testing and comparison, rather than detailed clinical study results typical of drug approvals or novel high-risk device PMA submissions.
Therefore, much of the requested information regarding detailed clinical studies, AI performance metrics, and expert consensus for ground truth is not present in this document. The document describes a comparison to a predicate device (TissueLink Monopolar Floating Ball) to demonstrate substantial equivalence, which is a different regulatory pathway than proving novel clinical efficacy through extensive trials with acceptance criteria based on patient outcomes or AI accuracy.
Here's the information that can be extracted and an explanation of why other requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with numerical targets and reported performance. Instead, the "acceptance criteria" here are implied by the demonstration of substantial equivalence to the predicate device. This typically means the new device performs similarly in terms of safety and effectiveness characteristics relevant to its intended use.
The document states: "Claim of Substantial Equivalence of the TissueLink Solid Cylinder monopolar device is made to: TissueLink Monopolar Floating Ball". This is the primary "acceptance criterion" for a 510(k) submission: demonstrating that the new device is as safe and effective as a legally marketed predicate.
Reported Device Performance (Implicit): The FDA's clearance letter ("MAR 2 7 2002") confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the performance (safety and effectiveness) as demonstrated in the submission was sufficient to meet the substantial equivalence standard. The specific performance parameters tested and their results are not detailed in this summary. These would typically include bench testing for electrical safety, electromagnetic compatibility, power output, tissue effects (e.g., coagulation depth, dissection speed), and biocompatibility.
2. Sample sized 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 summary. For a 510(k) submission of this type (electrosurgical device), testing would primarily involve bench testing, animal studies, and potentially limited human use data to confirm safety and performance relative to the predicate. The summary does not specify sample sizes for any tests, data provenance, or whether data was retrospective or prospective.
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 applicable/provided. The concept of "ground truth" established by experts, as typically seen in AI/diagnostic device studies, is not a primary component of a 510(k) submission for an electrosurgical device. Performance is typically assessed through objective measurements (e.g., power output, thermal spread) and potentially histology from animal models, rather than expert interpretation of images or observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical trials and diagnostic studies where interpretations or events need to be confirmed by multiple experts. This is not relevant for the type of device and regulatory submission presented.
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 applicable. This is an electrosurgical device, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers improving 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
This information is not applicable. This is an electrosurgical device, not an algorithm or AI system. Its performance is always "human-in-the-loop" as it is operated by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" as typically discussed in AI/diagnostic studies is not directly applicable. If any "ground truth" were to be considered, it would likely be based on:
- Bench Test Standards: Adherence to established engineering and electrical safety standards.
- Animal Models: Histological analysis of excised tissue from animal studies to assess coagulation depth, tissue damage, etc., compared to the predicate device.
- Performance Metrics: Objective measurements of device function (e.g., power delivery, impedance) under various conditions.
The specific details of these are not provided in the summary.
8. The sample size for the training set
This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, this is not an AI/machine learning device.
Summary of what is known from the provided text:
- Device Type: Electrosurgical Cauterizing Pen (TissueLink Solid Cylinder monopolar device).
- Predicate Device: TissueLink Monopolar Floating Ball.
- Regulatory Pathway: 510(k) Pre-Market Notification, demonstrating substantial equivalence to a predicate device.
- Indications for Use: Sterile, single use, electrosurgery device used with an electrosurgical generator for radiofrequency current and saline delivery, for blunt dissection and hemostasis of soft tissue in endoscopic and open abdominal and thoracic surgery. Not for contraceptive tubal coagulation.
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
The provided document is too brief and of a different regulatory scope to contain the detailed clinical study and AI-specific information requested. It's a regulatory clearance document for a relatively mature technology where safety and performance are established through comparison to a well-understood predicate.
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510(k) Premarket Submission - TissueLink Medical, Inc. - Solid Cylinder monopolar device
MAR 2 7 2002
510(k) Summary of Safety and Effectiveness
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Application Information:
| Date Prepared: | December 21, 2001 |
|---|---|
| Submitter: | TissueLink Medical Inc. |
| Address: | One Washington Center Suite 400Dover, NH 03820 |
| Contacts: | Vicki S. AnastasiDirectory Regulatory Affairs |
| Telephone Number: | (508) 922-1622 |
| FAX Number: | (508) 497-9925 |
| Roberta L. ThompsonVice President, Clinical, Regulatory and Quality | |
| Telephone Number: | (603) 742-1515 ext. 106 |
| Fax Number: | (603) 742-1488 |
| Device Information: | |
| Trade Name: | TissueLink Solid Cylinder monopolar device |
| Common Name: | Electrosurgery Cauterizing Pen |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories, 21CFR 878.440 |
Claim of Substantial Equivalence of the TissueLink Solid Cylinder monopolar device is made to:
TissueLink Monopolar Floating Ball
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Ms. Vicki S. Anastasi Director, Regulatory Affairs TissueLink Medical, Inc. Suite 400 One Washington Center Dover. NH 03820
Re: K014260
Trade/Device Name: TissueLink Solid Cylinder Monopolar Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 21, 2001 Received: December 27, 2001
Dear Ms. Anastasi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use Stated in the enorosale) to tegans and the Medical Device Amendments, or to connineres prior to May 20, 1976, the excordance with the provisions of the Federal Food. Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicierole, thanker the act include requirements for annual registration, listing of general volurola provisions 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 If your device is olassinod (600 as 10) of the major regulations affecting your device can may be subject to such additions, 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 r lease oc advised that i Dri brounder over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I oderall the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Fee orequirements) ; good manufacturing practice requirements as set CI It Fart 6077, adoling (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. Vicki S. Anastasi
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Submission – TissueLink Medical, Inc. – Solid Cylinder monopolar device
Indications for use Statement
Page of of
< 014260 510(k) Number (if known):__
Device Name:
TissueLink Solid Cylinder monopolar device
Indications for Use:
The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an I like insurgical generator for delivery of radio is current and saline for blunt dissection, hemostation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use Optional Format 1-
(Per 21 CFR 801.109)
muni
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_Ko14260
§ 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.