(89 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the device for surgical procedures and does not mention any AI/ML components or functionalities.
Yes
The device is used to facilitate coagulation, transection, mobilization, and dissection of tissue, which are therapeutic actions.
No
The device is described as facilitating surgical procedures (coagulation, transection, mobilization, dissection of tissue) using electrical current, not for identifying a disease or condition.
No
The device description clearly outlines physical hardware components (handle, shaft, distal tip, cautery connector/cable) and its connection to an RF generator, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "coagulation, transection, mobilization, and dissection of tissue" during surgical procedures. This involves direct interaction with the patient's body for therapeutic or surgical purposes.
- Device Description: The description details a surgical instrument with a handle, shaft, and distal tip configurations like dissectors, scissors, and cutting forceps. It also mentions connection to an RF generator for electrical current, which is used for surgical effects (like cautery).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, mobilization, and dissection of tissue.
Product codes
NUJ
Device Description
Laparoscopic electric instruments are devices that are designed for use via laparoscopes or open surgical procedures. The devices have a handle, a rotating insulated shaft with a diameter of 5mm, a length of 19-33 cm and a distal tip. The distal tip of the devices consists of a variety of configurations including: dissectors, scissors and cutting forceps. The devices may be monopolar or bipolar and have a cautery connector on the handle or a connector cable. The device is connected via a cautery cable to a RF generator which provides electrical current to the device.
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
Representative samples of reprocessed laparoscopic electric instruments underwent functional testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The symbol is composed of three interconnected human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2007
SterilMed, Inc. % Mr. Dennis Toussaint Director, Regulatory Affairs 11400 73rd Avenue North Maple Grove, Minnesota 55369
Re: K012598 - Supplemental Validation Submission Trade/Device Name: Reprocessed Electric Instruments (Enclosed List) Regulation Number: 21CFR878.4400 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories Regulatory Class: II Product Code: NUJ Dated: August 8, 2001 Received: August 10, 2001
Dear Mr. Toussaint:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on October 23, 2000. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these 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 (PMA) they 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 devices 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 devices comply 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 applicable 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
1
Page 2 - Mr. Dennis Toussaint
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure Intended Use form
2
Image /page/2/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in a bold, sans-serif font. Below the company name, it says "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The text is black and the background is white.
SVS For 510(K): K012598 Reprocessed Laparoscopic Electric Instruments
INDICATIONS FOR USE PAGE (K012598)
(Same as currently cleared 510(k))
Device Name: Reprocessed Laparoscopic Electric Instruments
Indications for Use: Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, mobilization, and dissection of tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Melkerson
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K012598
3
List of thirteen (13) Reprocessed Laparoscopic Electric Instruments
of the SVS for K012598
| Manufacturer | Model # | Description |
|---|---|---|
| AutoSuture | 174301 | Endo Mini-Shears, 5mm, Monopolar, 31cm |
| 174501 | EndoShears, 5mm, Monopolar, 19cm | |
| 174503 | Endo Mini-Shears, 5mm, Monopolar, 19cm | |
| 174505 | Endo Dissect, 5mm Monopolar, 19cm | |
| 176605 | EndoSciz, 5mm, Monopolar, 31cm | |
| 176643 | EndoShears, 5mm, Monopolar, 31cm | |
| 176645 | EndoDissect, 5mm, Monopolar, 31cm | |
| Ethicon | 5DCS | Scissors, 5mm, Monopolar, 31cm |
| 5DCD | Dissector, 5mm, Monopolar, 31 cm | |
| Everest (Gyrus) | 3005 | Cutting Forceps, 5mm, Bipolar, 33cm |
| 3025 | Cutting Forceps, 5mm, Bipolar, 24cm | |
| Gyrus | 3005PK | Cutting Forceps, 5mm, Bipolar, 33cm |
| 3025PK | Cutting Forceps, 5mm, Bipolar, 24cm |
:
:
4
SUPPLEMENTAL VALIDATION SUBMISSION JUNE 27, 2006
For 510(K): K012598 Reprocessed Laparoscopic Electric Instruments
SVS for K012598, Reprocessed Lap. Ele. Instruments
II. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Labels | Values |
|---|---|
| Submitter: | SterilMed, Inc. |
| Contact Person: | Dennis Toussaint |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 888-856-4870 | |
| Fax: 763-488-3350 | |
| Date Prepared: | June 28, 2006 |
| Trade Name: | Reprocessed Laparoscopic Electric Instruments |
| Classification Name: | Endoscopic Electrosurgical Accessory |
| Classification Number: | Class II, 21 CFR 878.4400 |
| Product Code: | NUJ |
Predicate
Devices:
Device
Description:
Intended Use:
Functional and
Safety Testing:
Page 1 of 2
The reprocessed laparoscopic electric instruments are substantially
equivalent to BiCoag Forceps (K945975), manufactured by Everest;
Endopath Endoscopic Instruments (K984240) manufactured by
Ethicon; and counterpart devices from other original equipment
manufacturers.
Laparoscopic electric instruments are devices that are designed for use
via laparoscopes or open surgical procedures. The devices have a
handle, a rotating insulated shaft with a diameter of 5mm, a length of
19-33 cm and a distal tip. The distal tip of the devices consists of a
variety of configurations including: dissectors, scissors and cutting
forceps. The devices may be monopolar or bipolar and have a cautery
connector on the handle or a connector cable. The device is connected
via a cautery cable to a RF generator which provides electrical current
to the device.
Laparoscopic electric instruments are designed for use in minimally
invasive procedures and/or open surgical procedures to facilitate
coagulation, transaction, resection, mobilization and dissection of
tissue.
Representative samples of reprocessed laparoscopic electric
instruments underwent functional testing to demonstrate appropriate
functional characteristics. Process validation testing was done to
validate the cleaning and sterilization procedures as well as device
packaging. In addition, the manufacturing process includes visual and
functional testing of all products produced.
5
STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
SUPPLEMENTAL VALIDATIC SUBMIS JUNE 27, 2006
For 510(K): K012598 Reprocessed Laparoscopic Electric Instruments
Conclusion:
The reprocessed laparoscopic electric instruments are substantially equivalent to BiCoag Forceps (K945975), and Endopath Endoscopic Instruments (K984240), manufactured by Ethicon; and counterpart devices from other original equipment manufacturers.
This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.