(133 days)
The Pivotal devices are sterile, disposable, general surgical instruments for use in endoscopic or open surgical procedures to dissect, transect, manipulate, coagulate, and/or grasp tissue.
The Pivotal instrument and similar currently marketed devices are intended to cut, grasp, manipulate, and coagulate tissue during surgical procedures. The similar marketed endoscopic devices are designed to be used with monopolar electrosurgery and are disposable devices supplied sterile to the user. These devices are available in a variety of blade and jaw configurations. These devices have similar thermoplastic ringed handles that open and close the jaws. The grasper devices are all equipped with a ratchet mechanism that allows the tissue to be held in the jaws without the need for applying constant pressure on the ringed handles.
The provided text is a 510(k) summary for the Pivotal Grasper, Pivotal Dissector, and Pivotal Scissors. This document is focused on demonstrating substantial equivalence to already marketed devices, rather than establishing specific performance acceptance criteria through a clinical study. Therefore, most of the requested information about acceptance criteria and a study proving the device meets them (especially in the context of AI development or human-in-the-loop performance) is not applicable to this type of regulatory submission.
The document states:
- "The Pivotal instrument is substantially equivalent to like devices in commercial distribution."
- "The Pivotal instruments perform the same function and have the same intended use as instruments distributed by Ethicon, United States Surgical Corporation (USSC), and Richard-Allan Medical."
- "The Pivotal instrument complies with the applicable safety, performance, and labeling requirements of the American National Standard Institute and the Association for the Advancement of Medical Instrumentation ANSI/AAMI HF18-1993 Standard for Electrosurgical Devices and ANSI/AAMI ESI-1993 Safe Current Limits for Electromedical Apparatus."
- "The method of sterilization and the method used to validate our sterilization process are in compliance with the ANSI/AAMI/ISO 1135-1994 Medical Devices-Validation and routine control of ethylene oxide sterilization."
Based on this, here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (as defined by referenced standards) | Reported Device Performance |
|---|---|
| Electrosurgical Safety: Compliance with ANSI/AAMI HF18-1993 Standard for Electrosurgical Devices | Complied |
| Electrosurgical Safety: Compliance with ANSI/AAMI ES1-1993 Safe Current Limits for Electromedical Apparatus | Complied |
| Sterilization: Compliance with ANSI/AAMI/ISO 1135-1994 Medical Devices-Validation and routine control of ethylene oxide sterilization | Complied |
| Substantial Equivalence: Perform same function and have same intended use as predicate devices (Ethicon, USSC, Richard-Allan Medical instruments) | Found to be substantially equivalent. |
| Material Equivalence: Components of similar materials (stainless steels, thermoplastics, braided fiberglass/epoxy, Teflon®) as predicate devices. | Equivalent materials used. |
| Tip Configuration Equivalence: Tip configurations (scissors, dissectors, graspers) equivalent to predicate devices. | Equivalent tip configurations. |
2. Sample size used for the test set and data provenance:
- Not applicable / Not specified. This document describes a substantial equivalence submission, which typically relies on comparisons to already proven predicate device designs and performance, not a new clinical test set with human readers, AI, or specific clinical outcomes. The "test set" here refers to the engineering evaluation against standards and predicate devices rather than a patient dataset.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable / Not specified. Ground truth in the context of this submission refers to technical standards compliance and functional equivalence, established through engineering analysis and comparison, not expert consensus on medical images or patient data.
4. Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for expert consensus on ambiguous medical cases; this is not relevant to a substantial equivalence submission for surgical instruments.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and its effect size:
- No. An MRMC study is not relevant to this type of device and submission. This is a 510(k) for basic surgical instruments, not an AI or imaging device that would involve human readers.
6. If a standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this submission is compliance with established industry standards (ANSI/AAMI) for electrosurgical safety and sterilization, and demonstrated functional and material equivalence to legally marketed predicate devices. There is no clinical outcomes data or pathology results mentioned.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this 510(k) submission. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this type of device.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for surgical instruments using engineering and material comparisons to predicate devices and compliance with existing standards. It does not involve the types of studies (e.g., AI performance, multi-reader studies) described in the prompt.
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NOV I 3 1997
Department of Health and Human Services June 30, 1997
APPENDIX B
Summary of Safety and Effectiveness
The Pivotal instrument is substantially equivalent to like devices in commercial distribution. Pivotal instruments perform the same function and have the same intended use as instruments distributed by Ethicon, United States Surgical Corporation (USSC), and Richard-Allan Medical.
The Pivotal instruments and similar currently marketed devices are intended to cut, grasp, manipulate, and coagulate tissue during surgical procedures. The similar marketed endoscopic devices are designed to be used with monopolar electrosurgery and are disposable devices supplied sterile to the user. These devices are available in a variety of blade and jaw configurations. These devices have similar thermoplastic ringed handles that open and close the jaws. The grasper devices are all equipped with a ratchet mechanism that allows the tissue to be held in the jaws without the need for applying constant pressure on the ringed handles.
The Auto Suture Endo Instruments, Auto Suture Roticulator Instruments, the Endopath Instruments, and the Reflex 5mm Laparoscopic Scissors are indicated for a variety of endoscopic procedures. The Ethicon PowerStar is indicated for general open surgical procedures. The Pivotal instrument is indicated for both open and endoscopic surgical procedures. This difference will not affect safety, effectiveness, or overall function of this type of device.
The Pivotal instrument and the endoscopic substantially equivalent devices are available in various tip configurations including scissors, dissectors, and graspers. The tip configurations of the Pivotal instruments are equivalent to devices being distributed by Ethicon and USSC.
The Pivotal instrument and other substantially equivalent devices contain components of similar materials; such as stainless steels, thermoplastics, braided fiberglass/epoxy, and Teflon®. The epoxy braided fiberglass material is used on Richard-Allan's currently marketed Reflex STR Trocar. The Teflon® material is used on Richard-Allan's currently marketed Reflex 5mm Laparoscopic Scissors.
The Pivotal instrument complies with the applicable safety, performance, and labeling requirements of the American National Standard Institute and the Association for the Advancement of Medical Instrumentation ANSI/AAMI HF18-1993 Standard for Electrosurgical Devices and ANSI/AAMI ESI-1993 Safe Current Limits for Electromedical Apparatus.
The method of sterilization and the method used to validate our sterilization process are in compliance with the ANSI/AAMI/ISO 1135-1994 Medical Devices-Validation and routine control of ethylene oxide sterilization.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
Ms. Julie Powell Ouality Assurance and Regulatory Affairs Director Richard - Allan Medical 8850 M89, Box 351 Richland, Michigan 49083-0351
Re: K972510
Trade Name: Pivotal Grasper, Pivotal Dissector, and Pivotal Scissors Regulatory Class: II ... . . ... . . .. Product Code: GEI Dated: October 7, 1997 Received: October 8, 1997
Dear Ms. Powell:
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 (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 devices in the Federal Register. Please note: this response to your premarket notification 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.
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Page 2 - Ms. Julie Powell
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) 594-4595. 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,
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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510(k) Number (if known):
Device Name: Pivotal Grasper, Pivotal Dissector, and Pivotal Scissor
Indications for Use:
The Pivotal devices are sterile, disposable, general surgical instruments for use in endoscopic or open surgical procedures to dissect, transect, manipulate, coagulate, and/or grasp tissue. ______________
(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 K972510
510(k) Number
Prescription Use (Per 21 CFR 801.109 ОЯ
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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.