(224 days)
The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose, Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Ultracision Harmonic Scalpel is a cutting and coagulating surgical instrument. The device system has three essential parts: the generator/foot-switch, the hand piece, and the blades. The blades are offered in a variety of configurations, shapes and sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ultracision Harmonic Scalpel:
It's important to note that the provided text is a summary of safety and effectiveness for a 510(k) submission to the FDA in 1999. It focuses on demonstrating substantial equivalence to predicate devices. As such, the level of detail regarding specific acceptance criteria and detailed study breakdowns (especially for AI/ML-related aspects) is not present because this device predates the widespread use of such methodologies in medical device clearances.
Missing Information: Many of the requested details (especially surrounding AI/ML, clinical study design, and detailed performance metrics) are not applicable or provided in this type of 510(k) summary for a surgical instrument from 1999.
Acceptance Criteria and Device Performance
The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. Specific quantitative performance metrics with defined acceptance thresholds are not explicitly listed in the provided summary as they might be for a novel diagnostic algorithm.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):
| Acceptance Criteria (Inferred for 510(k) Substantial Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Intended Use: Cut and coagulate soft tissues for specific surgical fields. | The device is intended for the same use as predicates. (The clearance implies this was accepted). |
| Bleeding Control: Achieve desired bleeding control. | "All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (This implies adequate bleeding control was observed.) |
| Minimal Thermal Injury: Minimize thermal injury. | "All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (This implies minimal thermal injury was achieved, as it's a key benefit of ultrasonic devices over electrosurgery). |
| Technological Characteristics: Be similar to predicate devices. | "The technological characteristics of the Ultracision Harmonic Scalpel are the same as the predicate devices. Ultrasonic technology is the method of activation." |
| Biocompatibility: Meet ISO 10993-1 for patient contact. | "The Harmonic Scalpel is constructed wholly of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile." |
| Safety and Effectiveness: Demonstrate satisfactory cutting and coagulation. | "All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (This is a general statement rather than specific quantitative data, but it satisfied the FDA for substantial equivalence). |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "bench and animal studies."
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Animal studies typically refer to non-human animal models.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified. The studies were likely performed by engineers, veterinarians, and/or surgeons associated with the manufacturer, rather than independent experts establishing a "ground truth" in the way it's done for diagnostic AI/ML algorithms.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not specified. This concept is typically relevant for expert-consensus ground truth in diagnostic studies, which is not described here.
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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. This is a surgical instrument from 1999, not an AI/ML diagnostic or assistive device. MRMC studies or AI assistance were not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a manually operated surgical instrument. The concept of "standalone algorithm performance" is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench studies, ground truth would be based on engineering measurements (e.g., cut speed, temperature profiles, dissection depths, tissue adherence).
- For the animal studies, ground truth would be based on direct observation of surgical outcomes by trained personnel (e.g., completeness of cut, quality of coagulation, absence of excessive thermal damage to surrounding tissue, healing response in long-term animal models if included). No specific ground truth methodology is detailed in this summary.
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The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set.
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Image /page/0/Picture/1 description: The image shows a black and white logo. The logo features a circle with a comet-like object inside. The comet has a bright, textured head and a tail consisting of four streaks that extend upwards and to the right. The overall design is simple and graphic.
THICON ENDO-SURGERY, INC.
K 990362
4545 CRFFK ROAD CINCINNATI. OH 45742-2839
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Ethicon Endo-Surgery, Inc4545 Creek RoadCincinnati, Ohio 45242 |
|---|---|
| Contact: | Ruth Ann Wood |
| Date: | February 5, 1999 |
| Device Name: | Ultracision Harmonic Scalpel |
| Predicate Devices: | Ultracision Harmonic Scalpel K983316, K941897,K924281Valley Labs Electrocautery Pencils K955109, K962044,K964602Colorado Microdissection Needle K881763Arthrocare Electrosurgery System K971532 |
| Device Description: | The Ultracision Harmonic Scalpel is a cutting andcoagulating surgical instrument. The device sys-tem has three essential parts: the generator/foot-switch, the hand piece, and the blades. The bladesare offered in a variety of configurations, shapesand sizes. |
Intended Use/Indications for Use:
The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose,Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
Technological Characteristics:
The technological characteristics of the Ultracision Harmonic Scalpel are the same as the predicate
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devices. Ultrasonic technology is the method of activation. The Harmonic Scalpel is constructed wholly of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.
Performance Data: Preclinical testing was performed to ensure the device performs as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three curved lines that suggest a person's head and torso.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1999
Ms. Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K990362 Trade Name: Ultracision Harmonic Scalpel Regulatory Class: II Product Code: LFL, GEI Dated: June 25, 1999 Received: June 28, 1999
Dear Ms. Wood:
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 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 (Premarket Approval), 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 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug 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 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. Ruth Ann Wood
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,
Salie M. Wittwer, Ph.D., M.D.
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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STO(K) WUMBER (IF KNOWN) : Ultracision Harmonic Scalpel DEVICE NAME:
INDICATIONS FOR USE:
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The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose, Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAG IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Us
(Optional Format:
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990362
§ 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.