(542 days)
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Trocars are devices inserted into a patient in order to maintain a clear pathway to facilitate the insertion of various surgical tools. Trocars are designed in both bladed and non-bladed configurations, however this submission is for non-bladed B5LTs. Non-bladed trocars require an incision be made before insertion into the patient's cavity. Trocars have a luer stopcock port for insufflation and desufflation of the patient's cavity. NES Reprocessed Endoscopic Trocars are sent from a user facility to be cleaned, sterilized and repackaged by NES. NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM).
The provided text describes the regulatory submission for a reprocessed medical device, the "NES Reprocessed Endoscopic Trocar." The focus of the submission is to demonstrate that the reprocessed device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating that the reprocessed device meets the same performance characteristics as the original, rather than establishing acceptance criteria for a novel algorithm or AI system.
Therefore, the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an algorithm's performance is largely not applicable to this document. The document focuses on showing that the reprocessed physical device has equivalent performance, safety, and effectiveness to its original, non-reprocessed counterpart.
Here's an analysis of the provided text in relation to your questions, highlighting why most are not directly addressed:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the typical sense for an algorithm. For a reprocessed physical device like a trocar, the "acceptance criteria" are generally that it functions identically and safely to the original device. This is demonstrated through various physical, chemical, and biological tests, not statistical performance metrics of an algorithm.
- The document states: "NES Reprocessed Endoscopic Trocars have the same intended use and performance characteristics equivalent to Endoscopic Trocars provided by Original Equipment Manufacturers (OEM)." and "NES Reprocessed Endoscopic Trocars operate as originally intended and are safe, effective and sterile as demonstrated by cleaning, packaging, performance, sterilization and biocompatibility testing."
- Implied Acceptance Criteria (based on the text):
- Functionality: Operates "as originally intended" and has "performance characteristics equivalent" to OEM. This would be assessed through mechanical testing (e.g., insertion force, structural integrity, insufflation seal).
- Safety: Demonstrated by "biocompatibility testing."
- Effectiveness: Functions as intended for its "intended use" (establishing a port of entry). This is a broad claim supported by the functionality.
- Sterility: Demonstrated by "sterilization testing."
- Cleaning/Reprocessing Efficacy: Demonstrated by "cleaning, packaging" assessments.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly mentioned. The document refers to "testing" but does not provide specific sample sizes for each type of test conducted (e.g., how many reprocessed trocars were tested for strength, sterility, or biocompatibility).
- Data Provenance: Not specified. It's implied that the testing was performed by Northeast Scientific, Inc., likely in the USA given their address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" in the algorithmic sense. The "ground truth" for a physical device's performance is typically established by engineering specifications, material science standards, and established medical device performance criteria, often determined by industry standards and regulatory guidance for reprocessed devices. The testing is objective against these standards, not against expert human interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, typically in diagnostic imaging or clinical trials involving subjective assessments. The tests for a medical device like a trocar are objective (e.g., tensile strength, leak rate, sterility tests), so adjudication by human experts is not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical medical instrument (trocar), not an AI algorithm. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective testing against predetermined physical, chemical, and biological standards. For a reprocessed device, the "ground truth" for showing substantial equivalence relies on proving that the reprocessed device performs identically to the original OEM device under various conditions (e.g., mechanical strength, sterility, biocompatibility). These are derived from established engineering and biological standards, not from expert consensus or pathology on a specific case.
8. The sample size for the training set
- Not applicable. This device is a reprocessed physical instrument, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm.
Summary regarding the provided text (K060676):
The document is a 510(k) summary for a reprocessed medical device. The "study" referenced is a series of tests to demonstrate that the reprocessed device meets the performance and safety characteristics of its original, non-reprocessed counterpart. These tests (cleaning, packaging, performance, sterilization, and biocompatibility) are designed to show substantial equivalence, not to prove the statistical performance of an AI algorithm against specific acceptance criteria in the manner you've outlined in your questions. Therefore, most of your specific questions are not directly answerable or applicable from this regulatory submission.
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| Section 2-1 | 510(k) Summary | ||
|---|---|---|---|
| Submitter | Northeast Scientific, Inc.29 S. Commons Rd.Waterbury, CT 06704 | SEP - 7 2007 | |
| Contact | Craig AllmendingerPresident & CEOPhone: 203-756-2111Fax: 203-757-5532Email: Allmendinger@sbcglobal.net | ||
| Date | August 31st, 2007 | ||
| Device | Trade Name: NES Reprocessed Endoscopic TrocarCommon Name: Non-Bladed TrocarClassification Name: Endoscope and accessoriesProduct Code: NLMDevice Class: Class IIOEM Models: Ethicon XCEL B5LT | ||
| Predicate Devices | 510(k) # | Trade Name | |
| K011538: | Endopath® Non-Bladed Solid Obturator Trocar | ||
| K011257: | Endopath® Non-Bladed Obturator Trocar System(5mm) | ||
| K990028: | Endopath® Optiview® Optical Surgical Obturatorand Sleeve | ||
| K971738: | Ethicon Endopath® Resposable Trocar System | ||
| K922608: | Endopath® EP Disposable Surgical Trocar | ||
| Indications for Use | NES Reprocessed Endoscopic Trocars are indicated for use toestablish a port of entry for endoscopic instruments in patientsrequiring minimally invasive surgical procedures. | ||
| Contraindications | NES Reprocessed Endoscopic Trocars are not intended to be usedon patients undergoing open surgical procedure and for whomendoscopic procedure has been contraindicated. | ||
| Device Description | Trocars are devices inserted into a patient in order to maintain aclear pathway to facilitate the insertion of various surgical tools.Trocars are designed in both bladed and non-bladedconfigurations, however this submission is for non-bladed B5LTs.Non-bladed trocars require an incision be made before insertioninto the patient's cavity. Trocars have a luer stopcock port forinsufflation and desufflation of the patient's cavity. NES | ||
| K060676 | Page 2 of 2 | ||
| Reprocessed Endoscopic Trocars are sent from a user facility to becleaned, sterilized and repackaged by NES. NES ReprocessedEndoscopic Trocars have the same intended use and performancecharacteristics equivalent to Endoscopic Trocars provided byOriginal Equipment Manufacturers (OEM). | |||
| TechnologicalCharacteristics | NES Reprocessed Endoscopic Trocars have identicaldesign, materials, characteristics and intended use as theOEM Trocars. | ||
| Test Data | NES Reprocessed Endoscopic Trocars operate as originallyintended and are safe, effective and sterile as demonstrated bycleaning, packaging, performance, sterilization andbiocompatibility testing. | ||
| Conclusion | Based on the information provided, NEScientific, Inc. concludesthat NES Reprocessed Endoscopic Trocars are safe, effective,perform as intended and are substantially equivalent to thepredicate devices identified herein. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2007
Northeast Scientific, Inc. % Mr. Craig Allmendinger President & CEO 29 South Commons Road Waterbury, Connecticut 06704
Re: K060676
Trade/Device Name: NES Reprocessed Endoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NLM Dated: August 8, 2007 Received: August 9, 2007
Dear Mr. Allmendinger:
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.
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Page 2 - Mr. Craig Allmendinger
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 premated 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson Dep. Dir.
9/16/05
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K06.676
Pape 0/7
Indications for Use
510(k) Number (if known): K060676
Device Name: NES Reprocessed Endoscopic Trocar
Indications For Use:
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number C060676
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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K060676 List of Reprocessed Device(s):
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| Description | Model Number | Size (ID/Length) |
|---|---|---|
| Ethicon XCEL Bladeless EndoscopicTrocar | B5LT | 5 mm diameter x 100 mm |
§ 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.