(89 days)
Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, mobilization, and dissection of tissue.
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.
The provided document is a 510(k) summary for reprocessed laparoscopic electric instruments. It details the device description, intended use, and a summary of functional and safety testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria and a detailed study proving the device meets those criteria, as typically found in a clinical study report or detailed validation protocol.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
Information available in the document:
- 1. A table of acceptance criteria and the reported device performance: Not explicitly provided in this format. The document generally states "functional testing to demonstrate appropriate functional characteristics" and "process validation testing to validate the cleaning and sterilization procedures as well as device packaging" but does not detail specific acceptance criteria or quantitative performance results against those criteria.
- 2. Sample size used for the test set and the data provenance: Not specified for the functional testing. The document states "Representative samples" were used.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This type of information is usually relevant for diagnostic devices involving expert review, not for reprocessed surgical instruments undergoing functional and safety testing.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/provided.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned as it's not relevant for this device type.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithms, not reprocessed medical devices.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For reprocessed devices, "ground truth" generally refers to meeting safety and functional specifications comparable to new devices, or demonstrating effective cleaning/sterilization. The document implies this was done through "functional testing" and "process validation testing," but doesn't detail the specific benchmarks or "ground truth" beyond "appropriate functional characteristics."
- 8. The sample size for the training set: Not applicable. This refers to AI/machine learning.
- 9. How the ground truth for the training set was established: Not applicable.
What the document does state regarding testing and validation:
- Functional and Safety Testing: "Representative samples of reprocessed laparoscopic electric instruments underwent functional testing to demonstrate appropriate functional characteristics." This implies a comparison to the function of original equipment manufacturer (OEM) devices, but no specifics are given.
- Process Validation: "Process validation testing was done to validate the cleaning and sterilization procedures as well as device packaging."
- Manufacturing Process: "In addition, the manufacturing process includes visual and functional testing of all products produced."
- Conclusion of Substantial Equivalence: The reprocessed devices are deemed substantially equivalent based on "similarities in functional design, materials, indications for use and methods of construction." This suggests that the testing aimed to confirm these similarities met an acceptable standard.
In summary, while the document confirms that functional and safety testing was performed, it does not provide the detailed acceptance criteria or the study results in a quantitative manner that would allow for filling the requested table or answering the specific questions about sample sizes, ground truth establishment, or expert involvement. The letter is an FDA clearance summary, which often provides generalizations about testing rather than the detailed technical reports themselves.
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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
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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
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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
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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 |
:
:
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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.
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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.
§ 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.