(118 days)
AED Bipolar Forceps are reusable devices (bipolar forceps/scissors and electrodes) that facilitate grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery). AED Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal ligation/coagulation for sterilization procedures. Do not use these bipolar forceps for these procedures.
AED Bipolar Forceps consist of
• Standard insulated bipolar handles
• Outer shaft with insulated tip
• Jaw inserts (forceps, scissors)
The device is reusable and provided non-sterile. The device must be cleaned and sterilized before use. All forceps are of the same basic design with differences in tip configurations.
This document is a 510(k) summary for the AED Bipolar Forceps, which is a medical device. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed performance study directly comparing the device against specific acceptance criteria for a new and innovative technology. Therefore, many of the typical questions for AI/algorithm performance studies are not directly applicable or available in this specific document.
However, I will extract the relevant information and indicate where details are not provided due to the nature of this type of regulatory submission.
1. A table of acceptance criteria and the reported device performance
For a medical device like the AED Bipolar Forceps, the "acceptance criteria" and "reported device performance" are framed in terms of meeting recognized safety and performance standards, and demonstrating substantial equivalence to legally marketed predicate devices. The document does not provide a table of numerical performance metrics for the device itself as one would expect for an AI algorithm. Instead, it refers to compliance with established electro-medical and sterilization standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance/Equivalence Claim) |
|---|---|
| IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (Fourth Edition, 2006) | The implication is that the AED Bipolar Forceps meet the safety requirements for high-frequency surgical equipment as outlined in this standard. The "Conclusion" section states: "Based on the technical information provided, intended use and performance information provided in this premarket notification, AED Bipolar Forceps have been shown to be substantially equivalent to the current legally marketed predicate devices." This substantial equivalence claim implies that its electrical safety and performance characteristics are comparable to predicate devices which would have also met such standards. |
| ISO 14937:2000: Sterilization of health care products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | The device is described as "reusable and provided non-sterile. The device must be cleaned and sterilized before use." Compliance with ISO 14937 indicates that the device's materials and design are compatible with and capable of being effectively sterilized according to validated processes, thus ensuring its safety for reuse. The "Conclusion" of substantial equivalence also implies that its sterilizability and reprocessing characteristics are comparable to predicate devices. |
Study that proves the device meets the acceptance criteria:
The document describes a "Design analysis and comparison" that confirms the basic functional characteristics are substantially equivalent to the predicate devices (Richard Wolf Medical Instruments, K023813; Stryker Endoscopic Instruments and Accessories, Stryker Endoscopy, K935237). This comparison is the primary "study" or evidence provided to the FDA for substantial equivalence. It is not a clinical trial or an AI performance study with a test set, experts, and ground truth in the typical sense for an AI/CADe device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/provided in this 510(k) summary. For a traditional medical device demonstrating substantial equivalence, a "test set" in the context of an AI algorithm is not used. The evaluation relies on engineering design, material specifications, and comparison to existing devices.
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 ground truth concept, as it applies to expert consensus or pathology for an AI algorithm's test set, is not relevant to this type of device submission. The "ground truth" here is the established safety and performance of the predicate devices and the compliance with international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the reasons stated above.
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/provided. MRMC studies are used for evaluating the impact of AI/CADe systems on human reader performance, which is not the scope of this 510(k) for a physical surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. There is no algorithm or AI component in the AED Bipolar Forceps to evaluate in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices and general medical device standards. This is not based on expert consensus, pathology, or outcomes data in the way it would be for an AI algorithm. Instead, it's based on engineering specifications, material science, and regulatory compliance frameworks for electrosurgical devices.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as the device is a physical instrument, not an AI algorithm.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set, there is no ground truth established for one.
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Koris53
510(k) Summary of Safety and Effectiveness
| Date: | May 29, 2008 |
|---|---|
| Submitter: | National Advanced Endoscopy Devices, Inc.22134 Sherman WayCanoga Park, CA 91303 |
| Telephone: | 818.227.2720 |
| Fax: | 818.227.2724 |
| Contact Person: | Gayle M. ButlerCompliance Manager |
| Product: | |
| Trade Name: | AED Bipolar Forceps |
| Classification: | Class II |
| Common Name: | Bipolar Forceps |
| Classification Name: | Device, Electrosurgical Cutting & Coagulation &Accessories (GEI, 21 CFR 878.4400) |
| Predicate Devices: | Bipolar Forceps, Richard Wolf Medical Instruments,Corp. K023813Stryker Endoscopic Instruments and Accessories,Stryker Endoscopy, K935237 |
| Device Description: | AED Bipolar Forceps consist of• Standard insulated bipolar handles• Outer shaft with insulated tip• Jaw inserts (forceps, scissors)The device is reusable and provided non-sterile. Thedevice must be cleaned and sterilized before use. Allforceps are of the same basic design with differencesin tip configurations. |
| Intended Use: | AED Bipolar Forceps are reusabledevices (bipolar forceps/scissors andelectrodes) that facilitate grasping, cuttingand manipulation of soft tissue duringlaparoscopic procedures with the use ofhigh frequency electrical current (bipolarelectrocautery). AED Bipolar Forcepshave not been shown to be effective fortubal sterilization or tuballigation/coagulation for sterilizationprocedures. Do not use these bipolarforceps for these procedures. |
| Comparison to Predicate Device: | Design analysis and comparison confirm that basicfunctional characteristics are substantially equivalent tothe predicate devices cited and raise no new issues ofsafety and effectiveness. |
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Image /page/1/Picture/0 description: The image contains a sequence of digits, specifically the number 1681553. The digits are written in a handwritten style, with some variations in thickness and stroke. The number appears to be written on a white background.
AED Bipolar Forceps Performance Standards:
IEC 60601 -2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (Fourth Edition, 2006).
ISO 14937:2000 Sterilization of health care products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.
- Based on the technical information provided, intended Conclusion: use and performance information provided in this premarket notification, AED Bipolar Forceps have been shown to be substantially equivalent to the current legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, clutching a staff entwined with a serpent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
SEP 2 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
National Advanced Endoscopy Devices, Inc. c/o Gayle M. Butler 22134 Sherman Way Canoga Park, CA 91303
Re: K081553
Trade/Device Name: AED Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 26, 2008 Received: August 29, 2008
Dear Ms. Butler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and it your le FDA finding of substantial equivalence of your device to a legally promaticated 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket -Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Mellersen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K08153 3
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INDICATIONS FOR USE
510(k) Number (if known): K081553
Device Name: AED Bipolar Forceps
Indications for Use:
AED Bipolar Forceps are reusable devices (bipolar forceps/scissors and electrodes) that facilitate grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery). AED Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal ligation/coagulation for sterilization procedures. Do not use these bipolar forceps for these procedures.
Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Pe. R. Rumm
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number
§ 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.