(226 days)
Not Found
Not Found
No
The summary describes reprocessed laparoscopic instruments for general surgical use and makes no mention of AI or ML.
No
The device is described as laparoscopic instruments for surgical procedures, indicating a diagnostic or interventional function rather than a therapeutic one.
No
The device description states it is intended for "cutting, grasping, dissection and electrocautery of tissue," which are surgical functions, not diagnostic ones.
No
The device is described as "Reprocessed Laparoscopic Instruments," which are physical surgical tools, not software. The summary provides no information suggesting a software component.
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 instruments are for use during surgery for cutting, grasping, dissection, and electrocautery of tissue. This describes a device used in vivo (within a living organism) for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside of the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Suretek Reprocessed Laparoscopic Instruments are intended for use during general and laparoscopic surgery for cutting, grasping, dissection and electrocautery of tissue.
Product codes
NUJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Not Found
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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2006
SureTek Medical % Mike Sammon, BME, Ph.D. CEO/President 44 Bellwood Farms Greenville, South Carolina 29607
Re: K052690 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: January 3, 2006 Received: January 6, 2006
Dear Dr. Sammon:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on May 12, 2006. 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 (2) CFR
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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.
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,
[signature]
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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Page 3 - Mike Sammon, BME, Ph.D.
Indications for Use
510 (k) Number (if known) : K052690
Suretek Reprocessed Laparoscopic Instruments Device Name:
Indications For Use:
Suretek Reprocessed Laparoscopic Instruments are intended for use during general and laparoscopic surgery for cutting, grasping, dissection and electrocautery of tissue.
Prescription Use AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices and Neurological Devices
Page 1 of
5100 Number
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.
- And 1998
:
Reprocessed Laparoscopic Instruments found to be substantially equivalent:
| AUTOSUTURE | ENDO DISSECT 5mm | Monopolar, 33cm Length |
|---|---|---|
| AUTOSUTURE | ENDO SCIZ 5mm | Monopolar, 33cm Length |
| AUTOSUTURE | ENDO SHEARS 5mm | Monopolar, 33cm Length |
| CONMED | Curved Metzenbaum, 5mm | Monopolar, 32cm Length |
| CONMED | Curved Metzenbaum, Narrow Tip, 5mm | Monopolar, 32cm Length |
| CONMED | Curved Metzenbaum, Mini, 5mm | Monopolar, 32cm Length |
| CONMED | Maryland Dissector, 5mm | Monopolar, 32cm Length |
| ETHICON | Dissector, 5mm | Monopolar, 33cm Length |
| ETHICON | Scissors, 5mm | Monopolar, 33cm Length |
| GYRUS | Bipolar Cutting Forceps, 5mm | 24cm Length |
| GYRUS | Bipolar Cutting Forceps, 5mm | 33cm Length |
| GYRUS | Bipolar Cutting Forceps, 10mm | 15cm Length |
| GYRUS | Bipolar Cutting Forceps, 10mm | 33cm Length |
| GYRUS | Bipolar Needle Electrode, 5mm | 33cm Length |
:
1000 - 1000
. .
.
: