(90 days)
The UltraCision 5mm LaparoSonic® Hook Blades and UltraCision HS2 Blade are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general and thoracic surgery, including the mobilization of the Internal Mammary Artery (IMA).
The UltraCision 5mm LaparoSonic® Hook Blade instruments are two styles of sterile, single patient use instruments consisting of a titanium blade with a non-removable sheath. The two styles consist of a Sharp Hook and Dissecting Hook. The working lengths are approximately 32 cm.
The UltraCision HS2 Blade is a sharp hook and has a working length of approximately 10 cm. The system consists of a blade affixed with a sheath, a hand piece, blade adaptor, blade wrench, generator, foot switch and cart.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ethicon Endo-Surgery, Inc. UltraCision devices:
This document is a 510(k) summary for the UltraCision 5mm LaparoSonic® Hook Blades and UltraCision HS2 Blade. It describes the device's substantial equivalence to a predicate device rather than presenting a novel clinical study with detailed acceptance criteria and performance metrics for a new AI-powered device. Therefore, many of the requested elements (like sample sizes, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable or not provided in this type of regulatory submission.
The core of this submission is to demonstrate "substantial equivalence" to a previously cleared device, meaning its safety and effectiveness are similar to the predicate, rather than proving performance against specific clinical benchmarks like an AI model would.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, formal acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated. The "acceptance criteria" are implicitly met by demonstrating that the new device performs acceptably and is as safe and effective as the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable performance in cutting soft tissue | Demonstrated acceptable performance in cutting. |
| Acceptable performance in blunt tissue dissection | Demonstrated acceptable performance in blunt tissue dissection. |
| Acceptable performance in coagulation | Demonstrated acceptable performance in coagulation. |
| Functionality in the mobilization of the Internal Mammary Artery | Demonstrated acceptable performance in the mobilization of the IMA. |
| Device can be used as designed. | Studies demonstrated acceptable performance. |
| Technological characteristics are the same as the Predicate Device | Confirmed: "The technological characteristics of the New Devices are the same as the Predicate Device." |
| Same ultrasonic characteristics as a method of activation | Confirmed: "The same ultrasonic characteristics remain as a method of activation." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document refers to "pre-clinical laboratory evaluations" but does not detail the number of samples or tests conducted.
- Data Provenance: Not specified, but generally, pre-clinical lab evaluations would be conducted in a controlled lab setting, likely in the country of manufacture (e.g., USA, where Ethicon is based). The studies were retrospective in the sense that they evaluated the device's performance, but not in the context of analyzing previously collected patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. As this involves pre-clinical lab evaluations of physical device performance (cutting, coagulation), the "experts" would likely be engineers, technicians, or surgeons involved in product development and testing, rather than clinical experts establishing a medical "ground truth" on patient data.
4. Adjudication Method for the Test Set
- Not applicable. This type of pre-clinical bench testing does not involve adjudication as would be found in clinical or AI performance studies where multiple readers interpret images or data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done. This document focuses on the direct performance of the surgical instrument itself in pre-clinical settings, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical surgical instrument, not an algorithm or AI system. Its performance ("standalone") is how it functions mechanically and ultrasonically in lab evaluations. The "pre-clinical laboratory evaluations" are essentially the standalone performance tests for this medical device.
7. The Type of Ground Truth Used
- The "ground truth" was established based on direct observation and measurement of physical effects (cutting, blunt dissection, coagulation, and IMA mobilization) in pre-clinical laboratory settings. This would involve objective assessment of tissue effects, speed, and consistency, rather than medical "ground truth" derived from patient outcomes, pathology, or expert consensus on clinical data.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device does not involve a "training set" or its associated ground truth establishment.
In summary: The provided document is a 510(k) summary focused on demonstrating the substantial equivalence of a surgical device to a predicate device based on its technological characteristics and acceptable performance in pre-clinical laboratory evaluations. It does not contain the detailed information typically associated with complex AI or clinical diagnostic device studies involving specific acceptance criteria measured against clinical ground truths, reader studies, or training/test sets.
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Image /page/0/Picture/3 description: The image shows a logo with a circular design on the left and text on the right. The circular design features curved lines that resemble a hand or a plant. To the right of the logo, the word "ETHIC" is written in block letters. Below "ETHIC", the name "Johnson" is written in cursive.
ETHICON ENDO-SURGERY, INC. on John ron company
- A.C.L.O.S.A.N.
A.C.L.O.S.A.N. - 45242285
K 971302 JUL - 7 1997
510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under theFederal Food, Drug and Cosmetic Act, respecting safety and effectiveness issummarized below For the convenience of the Reviewer, this summary isformatted in accordance with the Agency's final rule "...510(k) Summaries and510(k) Statements..." (21 CFR § 807) and can be used to provide a substantialequivalence summary to anyone requesting it from the Agency. |
|---|---|
| Devicedescription | The UltraCision 5mm LaparoSonic® Hook Blade instruments are two stylesof sterile, single patient use instruments consisting of a titanium blade with anon-removable sheath. The two styles consist of a Sharp Hook and DissectingHook. The working lengths are approximately 32 cm.The UltraCision HS2 Blade is a sharp hook and has a working length ofapproximately 10 cm. The system consists of a blade affixed with a sheath, ahand piece, blade adaptor, blade wrench, generator, foot switch and cart. |
| Intended use | The intended use for the New Device is the same as that of the PredicateDevice in that it is intended for cutting soft tissue and providing hemostasis ingeneral and thoracic surgery. |
| Indicationsstatement | The UltraCision 5mm LaparoSonic® Hook Blades and UltraCision HS2 Bladeare indicated for soft tissue incisions when bleeding control and minimalthermal injury are desired.The instruments can be used as an adjunct to or substitute for electrosurgery,lasers, and steel scalpels in general and thoracic surgery, including themobilization of the Internal Mammary Artery (IMA). |
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510(k) Summary of Safety and Effectiveness, Continued
| Technologicalcharacteristics | The technological characteristics of the New Devices are the same as thePredicate Device. The same ultrasonic characteristics remain as a method ofactivation |
|---|---|
| Performancedata | Pre-clinical laboratory evaluations were performed to ensure that the devicecan be used as designed. The studies demonstrated acceptable performance incutting, blunt tissue dissection and coagulation in the mobilization of the IMA. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) andthe information provided herein, we conclude that the New Devices aresubstantially equivalent to the Predicate Device under the Federal Food,Drug and Cosmetic Act. |
| Contact | Lonnie PaceEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242Work phone (513) 786-7141FAX number (513)786-7134 |
| Date | April 4, 1997 |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three flowing lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lonnie Pace Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
JUL - 7 1997
Re: K971302 UltraCision™ 5mm Hard Sheath LaparoSonic® Hook Blades and UltraCision™ HS2 Blade Regulatory Class: Unclassified Product Code: LFL Dated: April 4, 1997 Received: April 8, 1997
Dear Mr. Pace:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are 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, Druq, and Cosmetic Act (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class Il (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug
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Page 2 - Mr. Lonnie Pace
Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices 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 requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
[signature]
Celía M. Witten Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
Statement
The following is the indication for Use Statement:
510(k) Number K_971302 Device Name UltraCision Smm Hard Sheath LaparoSonic® Bladc.and ... . ....... UltraCision HS2 Blade
Indications for Usc
The UltraCision Smm LaparoSonic® Hook Blades and UltraCision HS2 Blade are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general and thoracic surgery, including the mobilization of the Internal Mammary Artery (IMA).
(! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Off Divisio reral Restorative Dev 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
N/A