(85 days)
Respective Ethicon Endo-Surgery ENDOPATH® and AutoSuture® endoscopic instruments legally marketed under various 510(k) premarket notifications.
Not Found
No
The 510(k) summary describes a reprocessed electrosurgical instrument and its intended use for grasping, dissection, and cauterization. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an electrosurgical instrument for grasping, mobilization, dissection, transection, and cauterization of tissue during minimally invasive surgery. These functions are surgical tools rather than direct therapeutic treatments aimed at curing or alleviating a disease or condition. While surgery can be therapeutic, the device itself is an instrument for the surgical process.
No
The device is described as an electrosurgical instrument used for grasping, dissection, cauterization, and transection of tissue during surgery. Its functions are therapeutic and interventional, not diagnostic.
No
The device is a physical surgical instrument used for grasping, dissection, and cauterization, and the description focuses on its mechanical and electrical components and reprocessing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the devices as being used during minimally invasive surgery for grasping, mobilization, dissection, transection, and cauterization of tissue. These are all procedures performed on the patient's body.
- Device Description: The description details a surgical instrument used for manipulating tissue and applying electrocautery within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Dissector instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for grasping, mobilization, dissection and/or cauterization of tissue.
Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, NUJ
Device Description
The electrosurgical instrument is used for grasping, dissection and cauterization in endoscopic general surgery. The distal instrument scissors or jaws are opened and closed using ring loop handles. The instrument shaft is insulated and designed for use with an appropriately sized trocar cannula; the shaft can be rotated 360° in either direction using a handle knob. Devices with electrocautery capability are supplied with a pin for connection to a compatible electrosurgical unit; use of the device for monopolar electrocautery requires use of a patient grounding pad. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.
Vanguard receives previously used electrosurgical instruments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility.
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
Healthcare facilities
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)
Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective.
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.
Respective Ethicon Endo-Surgery ENDOPATH® and AutoSuture® endoscopic instruments legally marketed under various 510(k) premarket notifications.
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
K012 700
JUL 2 9 2005
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC
Director, Regulatory Affairs
(863) 683-8680 (voice)
(863) 683-8703 (facsimile)
hcrawford@safe-reuse.com |
| Date | June 08, 2005 |
| Device | Trade Names: Vanguard Reprocessed Electrosurgical InstrumentsCommon Name: Endoscopic surgical instruments, laparoscopic surgical instrumentsClassification: 21 CFR 876.1500 - Endoscope and accessories – Class IIProduct Code: GCJ |
| Predicate Devices | Respective Ethicon Endo-Surgery ENDOPATH® and AutoSuture® endoscopic instruments legally marketed under various 510(k) premarket notifications. |
| Indications for Use | Dissector instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for grasping, mobilization, dissection and/or cauterization of tissue. |
| | Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue. |
| Contra-indications | This device is not intended for contraceptive coagulation of fallopian tissue or applications where minimally invasive surgery is contraindicated. |
| | Continued on next page |
ENDOPATH is a registered trademark of Ethicon Endo-Surgery, Inc. , a Johnson & Johnson company AutoSuture is a registered trademark of United States Surgical, a division of Tyco Healthgroup LP
.
1
510(k) Summary of Safety & Effectiveness, Continued
| Device Description | The electrosurgical instrument is used for grasping, dissection and cauterization in endoscopic general surgery. The distal instrument scissors or jaws are opened and closed using ring loop handles. The instrument shaft is insulated and designed for use with an appropriately sized trocar cannula; the shaft can be rotated 360° in either direction using a handle knob. Devices with electrocautery capability are supplied with a pin for connection to a compatible electrosurgical unit; use of the device for monopolar electrocautery requires use of a patient grounding pad. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.
Vanguard receives previously used electrosurgical instruments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to a healthcare facility. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics | Vanguard reprocessed electrosurgical instruments are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. Device materials, specifications, and technological characteristics are equivalent. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial Equivalence" Decision Making Process Chart, we conclude that the Vanguard reprocessed electrosurgical instruments are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2005
Ms. Heather Crawford, RAC Director, Regulatory Affairs Vanguard Medical Concepts Inc. 5307 Great Oak Drivce Lakeland, Florida 33815-3113
Re: K012700
Trade/Device Name: Vanguard Reprocessed Electrosurgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: April 21, 2005 Received: April 22, 2005
Dear Ms. Crawford:
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. Heather Crawford, RAC
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 a legally 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hyph Rlurdu
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
The Original Equipment Manufacturers (OEMs) and device models in this SVS application K012700 are:
| OEM | Model# | Diameter | Length | Description |
|---|---|---|---|---|
| Ethicon | ||||
| w/unipolar cautery | 5DCD | 5mm | 32cm | Curved Dissector |
| Ethicon | ||||
| w/unipolar cautery | 5DCS | 5mm | 32cm | Curved Scissors |
| US Surgical | ||||
| Mini-Shears | ||||
| cautery | 174301 | 5mm | 32.5cm | AutoSuture Endo |
| w/unipolar | ||||
| US Surgical | ||||
| Shears | ||||
| w/unipolar cautery | 176643 | 5mm | 33cm | AutoSuture Endo |
| US Surgical | ||||
| Dissector Shears | ||||
| cautery | 176645 | 5mm | 33cm | AutoSuture Endo |
| w/unipolar |
Stupt Rurda
(Division Sign-Off) Division of General, Restorative. and Nearological Devices
510(k) Number K012700
5
Indications for Use
K012700 510(k) Number (if known):
Device Name: Vanguard Reprocessed Electrosurgical Instruments
Indications for Use:
Dissector instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for grasping, mobilization, dissection and/or cauterization of tissue.
Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hupt Church
(Division Sign-Off)
Division of General, Restorative and in- ological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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