(175 days)
Not Found
No
The description focuses on mechanical and electrical functions of a surgical instrument, with no mention of AI/ML or data processing for decision-making or analysis.
No
The device is described as a scissor instrument used in minimally invasive surgery to mobilize, transect, and/or cauterize tissue, functioning as a surgical tool rather than a device intended for treating a disease or condition.
No
Explanation: The provided text describes the device as a surgical instrument used for mobilization, transection, and cauterization of tissue during minimally invasive surgery. Its function is to perform surgical actions, not to diagnose conditions.
No
The device description clearly outlines physical components like a handpiece, barrel, shaft, blades, and a cautery connector, indicating it is a hardware device.
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 used during minimally invasive surgery for "mobilization, transection and/or cauterization of tissue." This is a surgical procedure performed on the patient's body.
- Device Description: The description details a surgical instrument with scissors/jaws, a handpiece, and the ability to deliver cautery current. This is consistent with a surgical tool, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on testing these samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for direct intervention on the patient.
N/A
Intended Use / Indications for Use
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.
The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
Device Description
Endoscopic instruments consist of a rigid plastic handpiece with loop handles connected to the distal end scissors or jaws by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The handbiece loop handles operate the jaws. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The blades or jaws of endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.
Note: Only the Endoscopic Instrument (5DCS) is the subject of this submission, the electrosurgical unit and any other related equipment are not included in the scope of this submission. The only reprocessed model cleared in this submission is the Curved Scissor with Unipolar Cautery, Model 5DCS.
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Instruments. This included the following tests: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation. Performance testing demonstrates that Reprocessed Endoscopic Instruments perform as originally intended.
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.
0
SECTION 5: 510(k) SUMMARY
Submitter:
Contact:
Ascent Healthcare Solutions 10232 South 51st Street Phoenix, Arizona 85044
Amanda Babcock Senior Regulatory Affairs Specialist (480) 763-5300 (o) (863) 904-2312 (f) ababcock@ascenths.com
Date of preparation:
Name of device:
Predicate Device
Device description:
· K012700
Trade/Proprietary Name: Reprocessed Endoscopic Instruments
Classification Name: Electrosurgical, cutting & coagulation. accessories, laparoscopic & endoscopic, reprocessed
510(k) Title Vanquard Reprocessed Electrosurgical Instruments ENDOPATH® Endoscopic Instruments
January 21, 2011
Manufacturer Ascent Healthcare Solutions Ethicon Endo-Surgery. Inc.
18 2011
Endoscopic instruments consist of a rigid plastic handpiece with loop handles connected to the distal end scissors or jaws by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The handbiece loop handles operate the jaws. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The blades or jaws of endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.
Note: Only the Endoscopic Instrument (5DCS) is the subject of this submission, the electrosurgical unit and any other related equipment are not included in the scope of this submission.
Ascent Healthcare Solutions Reprocessed Endoscopic Instruments Traditional 510(k)
Page 14
1
Indications for Use:
Technological characteristics:
Performance data:
Conclusion:
Scissor instruments are used during minimally invasive surgery. in coniunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.
The design, materials, and intended use of Reprocessed Endoscopic Instruments are identical to the predicate devices The mechanism of action of Endoscopic Instruments is identical . to the predicate devices in that the same standard mechanical design and size and equivalent materials are utilized. There are no changes to the claims, intended use, clinical applications, . patient population, performance specifications, or method of operation. In addition, Ascent Healthcare Solutions' reprocessing of Endoscopic Instruments includes removal of adherent visible soil and decontamination. Each individual Endoscopic Instrument is tested for appropriate function of its components prior to packaging and labeling operations.
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Instruments. This included the following tests:
- . Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation.
Performance testing demonstrates that Reprocessed Endoscopic Instruments perform as originally intended.
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Endoscopic Instruments) are safe. effective, and substantially equivalent to the predicate devices as described herein.
Ascent Healthcare Solutions Reprocessed Endoscopic Instruments Traditional 510(k)
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ascent Healthcare Solutions % Ms. Amanda Babcock Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044
Re: K110189
JUL 18 2011
Trade Name: Reprocessed Endoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: July 6, 2011 Received: July 7, 2011
Dear Ms. Babcock:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Amanda Babcock
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K110189
Device Name: Reprocessed Endoscopic Instruments
Indications For Use:
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.
The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110189
Ascent Healthcare Solutions Reprocessed Endoscopic Instruments Traditional 510(k)
Page 13
5
The only reprocessed model cleared in this submission is the Curved Scissor with Unipolar Cautery, Model 5DCS.
(Division Sign-Off (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110189