(90 days)
Not Found
Not Found
No
The summary describes a conventional bipolar surgical scissor and does not mention any AI/ML components or functionalities.
Yes
The device is described as facilitating "cutting and bipolar coagulation of soft tissue in open surgical procedures," which are therapeutic actions aimed at treating or alleviating medical conditions.
No
The device is described as surgical scissors used for cutting and coagulating soft tissue, not for diagnosing medical conditions.
No
The device description clearly states it is a physical instrument (scissors) that connects to an electrosurgical generator, indicating it is a hardware device, not software-only.
Based on the provided information, the PowerStar Bipolar Scissors are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (outside the body).
- PowerStar Bipolar Scissors Function: The description clearly states that the PowerStar Bipolar Scissors are used to "cut and coagulate soft tissue in open surgical procedures." This is a direct surgical intervention performed in vivo (inside the body).
The device is a surgical instrument used for physical manipulation of tissue during surgery, not for testing samples outside the body.
N/A
- Intended Use / Indications for Use: "The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation. The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures." and "The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries".
- Product codes (comma separated list FDA assigned to the subject device): GEI
- Device Description: "The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation."
- Mentions image processing: Not Found
- Mentions AI, DNN, or ML: Not Found
- Input Imaging Modality: Not Found
- Anatomical Site: soft tissue
- Indicated Patient Age Range: Not Found
- Intended User / Care Setting: open surgical procedures
- Description of the training set, sample size, data source, and annotation protocol: Not Found
- Description of the test set, sample size, data source, and annotation protocol: Not Found
- Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results): "Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended. Sufficient data has been gathered from pre-clinical and clinical testing to assess the safety and effectiveness characteristics of the modified device."
- Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.): Not Found
- Predicate Device(s): Not Found
- Reference Device(s): Not Found
- Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc): Not Found
§ 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.
0
|C98136i/
SECTION 7
JUL 1 3 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act. respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
MODIFIED DEVICE PowerStar Bipolar Scissors NAME:
EXISTING (legally marketed) DEVICE NAME: PowerStar Bipolar Scissors
510(K) SUMMARY
Device Description
Intended Use
The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.
The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.
Continued on next page
PowerStar Bipolar Scissors ETHICON, Inc.
30
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Indications Statement
intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.
The PowerStar Bipolar Scissors are non-sterile, reusable devices
The modified device is technologically the same as the existing device.
Performance Data
Technological
Characteristics
Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended.
Sufficient data has been gathered from pre-clinical and clinical testing to assess the safety and effectiveness characteristics of the modified device.
Conclusions
Contact
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.
Gregory R. Jones Director Regulatory Affairs ETHICON, Inc. Rt. #22 West Somerville, NJ 08876-0151
. Date
PowerStar Bipolar Scissors ETHICON, Inc.
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles a human figure or a bird in flight, composed of curved lines and shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 1 3 1998
Mr. Gregory R. Jones Director Regulatory Affairs Ethicon, Inc. A Johnson & Johnson Company P.O. Box 151 Somerville, New Jersey 08876
Re: K981361 Trade Name: PowerStar Bipolar Scissors Regulatory Class: II Product Code: GEI Dated: April 10, 1998 Received: April 14, 1998
Dear Mr. Jones:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the 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, Drug, 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 II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (OS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification
3
Page 2 - Mr. Gregory R. Jones
submissions 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.
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 a legally marketed predicate device 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) 594-4648. 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,
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
4
510(k) Number (if known):
Device Name:
Indications for Use:
INDICATION FOR USE
PowerStar Bipolar Scissors
"The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries".
Surgical procedures would include, among others, the following:
General Surgery Bowel Breast Biopsies Hernia Repair Lysis of Adhesions Upper GI GI (other) Cholecystectomy Thyroid Splenectomy
OB/GYN Surgery Hysterectomy
Myomectomy
Endometriosis
Salpingo-oophrectomy
Ovariohysterectomy
Oncological Surgery Mastectomy Axillary Node Dissection
Plastic Surgery Mammoplasty Blepharoplasty Rhytidectomy Panniculectomy Forearm Pedicle Flap Facial
Urological Surgery Nephrectomy Prostatectomy Cystotomy
Ear. Nose & Throat Surgery Neck Mass Mastoidectomy
Tympanoplasty Tonsillectomy
Cardiovascular/Thoracic_Surgery Femoral Popliteal Bypass Internal Mammary Artery (IMA) Harvesting Pericardial Window Biopsy of the Thymus
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | Over-The Counter Use _______ (Optional Format 1-2-9G) |
PowerStar Bipolar Scissors
ETHICON, Inc.
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number |
iii
And And Andrew States