(92 days)
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
A Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.
Trocar Cannulae are available in sizes 5-15mm inner diameter and 70-100mm length. Cannulae are equipped with a pressure seal for maintenance of pneumopertineum during insertion and withdrawal of instruments. Some models are equipped with a luer stopcock port for insufflation and desufflation of the operative cavity. Some models are provided with stability anchors inserted over the cannula sleeve to help seal the incision site and maintain cavity pressure.
Trocar Obturator is available in bladed and non-bladed configurations sized 5-15mm. Bladed models are equipped with a safety shield designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated so as to reduce the risk for vascular or visceral injury.
Non-Bladed obturators have either a rounded (blunt) tip or sharply tapered (dilator) tip to allow trocar insertion following a cut down and minimize the risk for internal injury.
Vanguard receives previously used trocars from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.
This document describes the reprocessing of previously used trocars by Vanguard Medical Concepts, Inc. The submission is for "Vanguard Reprocessed Bladed and Non-Bladed Trocars" (US Surgical/AutoSuture Series). It outlines the device description, technological characteristics, and a conclusion of substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., "device must achieve X% accuracy"). Instead, it describes a demonstration of equivalence and performance through various validations. The "performance" is implicitly stated as performing "as intended" and being "safe and effective."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended | Reaches "Substantial Equivalence" to predicate devices. Validations demonstrate performance. |
| Device is safe and effective | Validations demonstrate safety and effectiveness. |
| Chemical safety (e.g., residual sterilization agents) | Sterilization validation (implied to ensure safety). Cleaning validation. |
| Biocompatibility | Biocompatibility testing. |
| Functionality (e.g., seal integrity, blade retraction, patency) | Performance testing. |
| Sterility Assurance | Sterilization validation. |
| Packaging integrity | Packaging validation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for performance testing of the reprocessed devices. It broadly mentions "cleaning, test data, biocompatibility testing."
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given this is a 510(k) for a reprocessed medical device, the testing would likely be a combination of in-house (Vanguard Medical Concepts) laboratory testing and potentially contract lab testing, using the specific devices being reprocessed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is generally not applicable to a 510(k) submission for reprocessing a medical device like a trocar. The "ground truth" for these devices is typically established through engineering specifications, regulatory standards, and performance characteristics of the original predicate device. Expert panels are not usually used to establish "ground truth" for the functionality of a reprocessed instrument, but rather to evaluate the clinical impact or equivalence. The document does not mention any expert panels.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human judgment is involved in establishing a definitive diagnosis or outcome, for example, in medical imaging studies. For the performance testing of a physical medical device, objective measurements against specifications are used, not human adjudication in this sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms where human readers' performance is compared with and without AI assistance across multiple cases. This submission is for the reprocessing of a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. A "standalone" performance study refers to the performance of an AI algorithm alone. This submission is for a reprocessed medical device, not an AI algorithm. The device itself is "standalone" in the sense that its functionality is evaluated independently of human surgical skill, but this is a different context than what is meant by "standalone" for AI.
7. The Type of Ground Truth Used
The ground truth used for this type of device (reprocessed trocars) would be:
- Engineering Specifications and Performance Standards: The reprocessed devices must meet the design and performance specifications of the original predicate devices (e.g., seal integrity, blade sharpness, safety shield function, structural integrity).
- Regulatory Standards: Adherence to FDA guidance for reprocessed single-use devices, including sterility, biocompatibility, and cleaning validation.
- Predicate Device Performance: The original predicate devices set the benchmark for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. A "training set" refers to data used to train an AI algorithm. This submission is for a reprocessed medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned in the context of an AI algorithm. The "ground truth" for the processes (cleaning, sterilization, etc.) would be established by validated scientific methods and regulatory requirements for medical device reprocessing.
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510(k) Summary of Safety & Effectiveness MAR 3 1 2005
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector of Regulatory Affairs863-683-8680, ext. 249 [voice]863-683-8703 [facsimile]hcrawford@safe-reuse.com [email] |
| Date | December 28, 2004 |
| Device | Trade Name: Vanguard Reprocessed Bladed and Non-Bladed Trocars(US Surgical/AutoSuture Series)Common Name: Bladed and Non-Bladed TrocarClassification Number: 21 CFR 876.1500Classification Name: Endoscope and accessoriesProduct Code: NLM - Laparoscope, General & Plastic Surgery,Reprocessed - Class II |
| PredicateDevices | Original equipment manufacturer (OEM) Bladed and Non-Bladed Trocars arecurrently marketed under a variety of trade names. Trade names of currentlegally marketed predicate devices are:US Surgical (AutoSuture) VersaPort™ V2 (5-12mm) Trocar System US Surgical (AutoSuture) VersaPort™ RPF (5-12mm) Trocar System US Surgical (AutoSuture) VersaPort™ RT (5-12mm) Trocar System US Surgical (AutoSuture) BluntPort™ (5-12mm) Trocar System US Surgical (AutoSuture) VersaStep™ (5-12mm) Trocar System US Surgical (AutoSuture) SpringGrip Anchoring Accessory The 510(k) Premarket Notification numbers for these devices are: K012539: VersaStep K963115: Trocar Cannula K954108: Modified VersaPort K945457: Trocar (Accessory) K931337: AutoSuture Dilating Cannula |
| Indicationsfor Use | Reprocessed trocars are intended to provide a pathway for entry ofinstruments during minimally invasive surgery, with particular applications inabdominal, gynecological, urological, and thoracic procedures. |
| Contra-indications | Reprocessed trocars should not be used in patients for whom endoscopicprocedure is contraindicated. |
| DeviceDescription | A Vanguard Reprocessed Trocar is a previously used device that has beencleaned, inspected, packaged and sterilized by Vanguard Medical Concepts,Inc. |
| Trocar Cannulae are available in sizes 5-15mm inner diameter and 70-100mm length. Cannulae are equipped with a pressure seal for maintenanceof pneumopertineum during insertion and withdrawal of instruments. Somemodels are equipped with a luer stopcock port for insufflation anddesufflation of the operative cavity. Some models are provided with stabilityanchors inserted over the cannula sleeve to help seal the incision site andmaintain cavity pressure. | |
| Trocar Obturator is available in bladed and non-bladed configurations sized5-15mm. Bladed models are equipped with a safety shield designed toexpose the blade during insertion but to retract over the tip once the operativecavity has been penetrated so as to reduce the risk for vascular or visceralinjury. | |
| Non-Bladed obturators have either a rounded (blunt) tip or sharply tapered(dilator) tip to allow trocar insertion following a cut down and minimize therisk for internal injury. | |
| Vanguard receives previously used trocars from healthcare facilities; cleans,inspects, tests, packages, labels, and sterilizes the devices; and returns them toa healthcare facility for subsequent use. | |
| TechnologicalCharacteristics | Vanguard Reprocessed Bladed and Non-Bladed Trocars are essentiallyidentical to the Original Equipment Manufacturer (i.e., AutoSuture®)devices. No changes are made to the device materials or specifications andthe reprocessed trocars possess identical technological characteristics. |
| Continued on next page |
Continued on next page
KO435
BluntPort™, VersaPort™, VersaStep™ and AutoSuture® are registered trademarks of United States Surgical, a division of Tyco Healthcarc
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KO43534 510(k) Summary of Safety & Effectiveness, Continued
sterilization, packaging validations, and performance and Cleaning, Test Data biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective. Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed Bladed and Non-Bladed Trocars are substantially equivalent to their legally marketed predicate devices under the Federal Food, Drug and Cosmetic Act.
BluntPort™, VersaPort™, VersaStep™ and AutoSuture® are registered trademarks of United States Surgical, a division of Tyco Healthcare
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human profiles facing to the right.
NOV 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044
Re: K043594 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CRF 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: March 7, 2005 Received: March 9, 2005
Dear Ms. Barton:
This letter corrects our substantially equivalent letter of March 31, 2005. The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 31, 2005. We have received your supplemental validation data as required for reprocessed singleuse 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
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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 wours,
Mark N. Mel kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (k) Number (if known) : K043594
Vanguard Reprocessed Bladed and Non-Bladed Trocars Device Name:
Indications For Use:
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
Prescription Use (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 )
evice Evaluation (ODE) Concurrence of CDRH, Offic
estoral e and Neurological
510(k) Nr
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List of Models:
US Surgical (AutoSuture)VersaPort™ V2 (5-12 mm) Trocar System US Surgical (AutoSuture)VersaPort™ RPF (5-12 mm) Trocar System US Surgical (AutoSuture)VersaPort™ RT (5-12 mm) Trocar System US Surgical (AutoSuture)BluntPort™ (5-12 mm) Trocar System US Surgical (AutoSuture)VersaStep™ (5-12 mm) Trocar System US Surgical (AutoSuture) SpringGrip Anchoring Accessory
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.