(118 days)
Not Found
No
The summary describes a standard reusable surgical instrument (bipolar forceps) and does not mention any AI or ML components or functionalities.
No
The device is used for grasping, cutting, and manipulation of soft tissue during laparoscopic procedures, and does not directly treat a disease or condition.
No
The device description states it is used for "grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current." This indicates a surgical or therapeutic function, not a diagnostic one.
No
The device description explicitly details physical components (handles, shaft, jaw inserts) and mentions reusability and sterilization, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery)." This describes a surgical instrument used on the body, not a device used to test samples from the body.
- Device Description: The description details the physical components of a surgical instrument (handles, shaft, jaw inserts).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical tool used during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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. The device must be cleaned and sterilized before use. All forceps are of the same basic design with differences in tip configurations.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Koris53
510(k) Summary of Safety and Effectiveness
| Date: | May 29, 2008 |
|---|---|
| Submitter: | National Advanced Endoscopy Devices, Inc. |
| 22134 Sherman Way | |
| Canoga Park, CA 91303 | |
| Telephone: | 818.227.2720 |
| Fax: | 818.227.2724 |
| Contact Person: | Gayle M. Butler |
| Compliance 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. K023813 | |
| Stryker 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. The
device must be cleaned and sterilized before use. All
forceps are of the same basic design with differences
in tip configurations. |
| Intended 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. |
| Comparison to Predicate Device: | Design analysis and comparison confirm that basic
functional characteristics are substantially equivalent to
the predicate devices cited and raise no new issues of
safety and effectiveness. |
1
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.
2
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.
3
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
4
K08153 3
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Page 1 of 1
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