(119 days)
Not Found
No
The summary describes standard reusable surgical accessories for electrosurgery and does not mention any AI or ML components or functionalities.
No.
The device is described as reusable accessories (forceps and electrodes) for general laparoscopic surgical procedures requiring electrosurgical cutting and/or coagulation, which are surgical tools, not therapeutic devices.
No
The "Intended Use / Indications for Use" states that the device is for "electrosurgical cutting and/or coagulation" in general laparoscopic surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of physical components like handles, shafts, inserts (forceps, scissors, etc.), and electrodes, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that these are "reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation." These are surgical instruments used directly on the patient during a procedure, not for testing samples outside the body.
- Intended Use: The intended use is for "general laparoscopic surgical procedures," which are invasive procedures performed on a patient.
Therefore, based on the provided information, this device falls under the category of surgical instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
AED Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated Shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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SEP 2 5 2008
. . .
АТТАСНМЕНТ В
510(k) Summary of Safety and Effectiveness
| Date: | May 22, 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 Monopolar Lap Accessories |
| Classification: | Class II |
| Common Name: | Laparoscopic Accessories for General & Plastic Surgery |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| (GCJ, 21 CFR 876.1500) | |
| Electrosurgical Cutting & Coagulation & Accessories | |
| (GEI, 21 CFR 878.4400) | |
| Predicate Devices: | Dan Monopolar Lap Accessories, Dannoritzer |
| Medizintechnik GmbH, K052759 | |
| Gyrus Open Forceps, Gyrus Medical, Inc., K024286 | |
| Device Description: | AED Monopolar Lap Accessories consist of |
| Standard insulated monopolar handlesInsulated ShaftsClass I inserts (forceps, scissors, biopsy cups, needle holders)Electrodes | |
| The device is reusable and provided non-sterile. It | |
| must be cleaned and sterilized before use. | |
| Intended Use: | AED Monopolar Lap Accessories are reusable |
| devices (forceps and electrodes) intended to be used in | |
| general laparoscopic surgical procedures requiring the | |
| use of electrosurgical cutting and/or coagulation. | |
| 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
K051503 p. Zotz
Performance Standards: AED Monopolar Lap Accessories 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. Conclusion: Based on the technical information provided, intended use and performance information provided in this premarket notification, AED Monopolar Lap Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, clutching a caduceus in its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
SEP 2 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
National Advanced Endoscopy Devices, Inc. % Ms. Gayle M. Butler Compliance Manager 22134 Sherman Way Canoga Park, California 91303
Re: K081503
Trade/Device Name: AED Monopolar Lap Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory 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
Page 2 - Ms. Gayle M. Butler
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally 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), 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 a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Milburn
- 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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p. l. r f. l
ATTACHMENT A
INDICATIONS FOR USE
Page _1_of _1
510(k) Number (if known): K081503
Device Name: AED Monopolar Lap Accessories
Indications for Use:
AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
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)
N.L.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Ic frI 503