(135 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.
Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.
Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 5-15cm 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 shielded and non-shielded configurations sized 5-15mm. Models equipped with a safety shield are 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-shielded optical obturators are equipped with a clear tip and an 11-12mm video laparoscopy channel to allow trocar insertion under direct visual guidance and minimize the risk for internal injury.
The provided text describes a 510(k) summary for Vanguard Reprocessed Dilating Tip and Blunt Trocars. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics for the reprocessed device. Therefore, much of the requested information regarding detailed study design, statistical analysis, and clinician-based performance metrics is not available within this document.
Here's an attempt to answer based on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally claims that "cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cleaning effectiveness | Not quantitatively stated. Implied as "successfully cleaned." |
| Sterilization effectiveness | Not quantitatively stated. Implied as "successfully sterilized." |
| Packaging integrity | Not quantitatively stated. Implied as "successfully packaged." |
| Performance (functional) | Not quantitatively stated. Implied as performing "as intended," and that "reprocessed trocars possess identical technological characteristics" to OEM devices. |
| Biocompatibility | Not quantitatively stated. Implied as "biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of evaluating algorithm performance or diagnostic accuracy. It refers to "cleaning, sterilization, packaging validations, and performance and biocompatibility testing" as the basis for demonstrating safety and effectiveness.
- Sample Size: Not specified for each type of testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's likely these were laboratory or bench tests conducted by Vanguard Medical Concepts, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a reprocessed medical device approval, not an AI/diagnostic software approval, the concept of "ground truth" derived from experts in a clinical diagnostic context does not apply in the same way. The ground truth for the reprocessed device's safety and effectiveness would be established through:
* Bench testing: Measuring physical properties, functional performance against specifications.
* Sterilization validation: Demonstrating sterility.
* Biocompatibility testing: Ensuring material safety.
No "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy are mentioned or relevant here.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic study requiring expert adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No MRMC comparative effectiveness study was done, as this is a device reprocessing approval for physical instruments, not a diagnostic AI or imaging interpretation system requiring human-in-the-loop performance evaluation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
As this concerns a reprocessed physical device, the "ground truth" refers to established engineering standards, material science specifications, and regulatory requirements for sterility and biocompatibility.
- Engineering Specifications: Functional performance validated against the original equipment manufacturer's (OEM) device specifications.
- Sterility Assessment: Meeting established sterility assurance levels (e.g., 10^-6).
- Biocompatibility Standards: Adherence to ISO 10993 or similar standards.
- Cleaning Efficacy Standards: Demonstrating removal of organic and inorganic contaminants to acceptable levels.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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510(k) Summary of Safety & Effectiveness
K043253/52
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector of Regulatory Affairs863-683-8680 [voice]863-683-8703 [facsimile]hcrawford@safe-reuse.com [email] |
| Date | November 23, 2004 |
| Device | Trade Name: Vanguard Reprocessed Dilating Tip and Blunt TrocarsCommon Name: Dilating tip/shielded trocar, Blunt/non-shielded trocar, Adjustable stability threadClassification Number: 21 CFR 876.1500Classification Name: Endoscope and accessoriesProduct Code: NLM - Laparoscope, General & Plastic Surgery, Reprocessed - Class II |
| Predicate Devices | Original equipment manufacturer (OEM) Dilating Tip and Blunt Trocars are currently marketed under a variety of trade names. Trade names of legally marketed predicate devices are: Ethicon ® Tristar ™ Blunt Tip Trocar (10mm-12mm)Ethicon ® Endopath ® Dilating Tip Trocar (5mm-12mm)Ethicon ® Endopath ® Optiview ® Optical Trocar (5mm-12mm)Ethicon ® Tristar ™ Pyramidal Blade Trocar (5mm-12mm)Ethicon ® Endopath ® Adjustable Stability Thread (5mm-12mm) The 510(k) Premarket Notification numbers for these devices are: K020428: Endopath ® Dilating Tip TrocarK011538: Endopath ® Non-Bladed Solid Obturator Trocar SystemK011257: Endopath ® Non-Bladed Obturator Trocar System (5mm)K990028: Endopath ® Optiview ® Optical Surgical Obturator and SleeveK971475: Shielded Surgical TrocarK963760: Non-Shielded Surgical Trocar and Sleeve |
Continued on next page
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510(k) Summary of Safety & Effectiveness, Continued
| 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 | Vanguard Reprocessed Trocar is a previously used device that has beencleaned, inspected, packaged and sterilized by Vanguard Medical Concepts,Inc. |
| Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-15mminner diameter and 5-15cm length. Cannulae are equipped with a pressureseal for maintenance of pneumopertineum during insertion and withdrawal ofinstruments. Some models are equipped with a luer stopcock port forinsufflation and desufflation of the operative cavity. Some models areprovided with stability anchors inserted over the cannula sleeve to help sealthe incision site and maintain cavity pressure. | |
| Trocar Obturator is available in shielded and non-shielded configurationssized 5-15mm. Models equipped with a safety shield are designed to exposethe blade during insertion but to retract over the tip once the operative cavityhas been penetrated, so as to reduce the risk for vascular or visceral injury.Non-shielded optical obturators are equipped with a clear tip and an 11-12mmvideo laparoscopy channel to allow trocar insertion under direct visualguidance and minimize the risk for internal injury. | |
| TechnologicalCharacteristics | Vanguard Reprocessed Dilating and Blunt Tip Trocars are essentiallyidentical to the Original Equipment Manufacturer (i.e., Ethicon®) devices.No changes are made to the device materials or specifications and thereprocessed trocars possess identical technological characteristics. |
| Test Data | Cleaning, sterilization, packaging validations, and performance andbiocompatibility testing demonstrate that the reprocessed devices perform asintended and are safe and effective. |
| Continued on next page |
ENDOPATH®, OPTIVIEW®, and TRISTAR™ are registered trademarks of Ethicon Endo-Surgery, Inc.
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510(k) Summary of Safety & Effectiveness, Continued
Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed Dilating Tip and Blunt Trocars are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font.
Public Health Service
NOV 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044
Re: K043253 - 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 April 8, 2005. The above-referenced premarket notification (510(k)) was cleared by the Office 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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Page 2 - Ms. Moira Barton
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.
Pur Salla
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 - Ms. Moira Barton
Indications for Use
510 (k) Number (if known) : ___K043253
Vanguard Reprocessed Bladed and Non-Bladed Trocars Device Name:
Indications For Use:
Reprocessed trocars are intended to provide a pathway for entry neproorments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.
AND / OR Prescription Use X (Part 21 CFR 801 Subpart D)
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)
Division of General, Restorative and Neurological Devices
Page 1 of
510(k) Number L043253
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Page 4 -- Ms. Moira Barton Page 4 – Ms. Moira Barton
| Device | Model Numbers |
|---|---|
| Ethicon® Endopath® Endopath Dilating TipTrocar, 5 mm-12 mm | 355LD, 355LM, 355SD, 355SM, 355TM, 511SD,511SM, 512SD, 512SM, 578SD |
| Ethicon® Endopath® Optiview OpticalTrocar 5 mm-12 mm | 35HS, 35HL, 35HST, 35HLT, 511H, 511HT,512HN, 512HT, 35NST, 35NLT, 35OS, 35OL,511NT, 511O, 512NT, 512ON |
| Ethicon® TristarTM Pyramidal Blade Trocar,5 mm-12 mm | 355L, 355S, 355T, 511S, 512S |
| Ethicon® TristarTM Blunt Tip Trocar,10 mm-12 mm | 512B |
| Ethicon® Endopath® Adjustable StabilityThread , 5 mm-12 mm | T355, T511, T512 |
100 - 100 - 100
§ 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.