(147 days)
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and the trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.
The provided text is a 510(k) Summary for a reprocessed medical device, the Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar. It asserts substantial equivalence to a predicate device based on functional performance studies, cleaning performance, biocompatibility, and sterilization and packaging validations. However, it does not contain the specific acceptance criteria (thresholds) for each performance test, nor does it present detailed "device performance" in a comparative table against those criteria. It also does not describe a "study that proves the device meets the acceptance criteria" in terms of clinical trials or multi-reader multi-case studies, but rather product verification and validation testing.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance numbers, sample sizes for test sets (beyond the implied "models included in clearance"), data provenance, expert ground truth, adjudication methods, or MRMC studies is not available in the provided document. The document describes a technical testing scheme for reprocessing rather than a study evaluating diagnostic AI performance.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Not explicitly stated as numerical thresholds in this document)
The document states that the functional characteristics were "evaluated and were found to be substantially equivalent to the predicate device based on the following tests." This implies that the acceptance criteria for the reprocessed device were to perform comparably to the original predicate device on these tests. Actual numerical or qualitative thresholds for "passing" these tests are not provided.
Reported Device Performance:
The document does not provide specific numerical or qualitative performance results for the reprocessed device. It only states that the device was "found to be substantially equivalent" based on the described tests.
| Test Category | Specific Test | Acceptance Criteria (Not explicitly stated as thresholds) | Reported Device Performance (Not explicitly stated as data) |
|---|---|---|---|
| Simulated Use | Simulated use and artificial soiling | Implying comparable performance to predicate | "Found to be substantially equivalent" |
| Functional Performance | Seal leakage | Implying comparable performance to predicate | "Found to be substantially equivalent" |
| Seal drag | Implying comparable performance to predicate | "Found to be substantially equivalent" | |
| Surface roughness | Implying comparable performance to predicate | "Found to be substantially equivalent" | |
| Visualization | Implying comparable performance to predicate | "Found to be substantially equivalent" | |
| Cleaning | Protein and carbohydrates | Implying comparable to established cleaning limits | "Found to be substantially equivalent" |
| Visual inspection | Implying comparable to established cleaning limits | "Found to be substantially equivalent" | |
| Cleaning performance qualification | Implying comparable to established cleaning limits | "Found to be substantially equivalent" | |
| Biocompatibility | Cytotoxicity (direct/indirect) | Implying passing standard biocompatibility tests | "Found to be substantially equivalent" |
| Irritation (direct/indirect) | Implying passing standard biocompatibility tests | "Found to be substantially equivalent" | |
| Sensitization (direct/indirect) | Implying passing standard biocompatibility tests | "Found to be substantially equivalent" | |
| Material-mediated pyrogenicity (direct/indirect) | Implying passing standard biocompatibility tests | "Found to be substantially equivalent" | |
| Acute systemic toxicity (direct/indirect) | Implying passing standard biocompatibility tests | "Found to be substantially equivalent" | |
| Sterilization & Packaging | Bioburden enumeration testing | Implying meeting sterilization standards | "Found to be substantially equivalent" |
| Ethylene oxide and ethylene chlorohydrin residuals | Implying meeting sterilization standards | "Found to be substantially equivalent" | |
| Product Stability | Product stability | Implying comparable to predicate stability | "Found to be substantially equivalent" |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document lists 15 specific reprocessed device models (combinations of diameter, length, and fixation/smooth cannula) that were included in the clearance. For each of these models, it implies that representative samples were tested across the various performance evaluations. However, the exact number of units tested for each specific test (e.g., how many devices were tested for seal leakage) is not provided.
- Data Provenance: The studies are described as "Performance Testing" conducted by the submitter, Medline ReNewal. This implies the data were generated prospectively as part of this 510(k) submission process for the reprocessed device. The country of origin for the data is not explicitly stated, but Medline ReNewal is based in Redmond, Oregon, USA, suggesting the testing was likely conducted in the USA or supervised by their US-based QA/RA department.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The device is a surgical trocar, not an AI/diagnostic imaging device where "ground truth" would typically be established by expert readers or pathology. The "ground truth" for this device's performance relies on engineering and biological safety standards for reprocessing and functional equivalence to the original device.
4. Adjudication method for the test set
- This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus in interpreting images or clinical data, which is not relevant to the described performance testing of a surgical instrument.
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
- This information is not applicable and not provided. This is not an AI-assisted diagnostic device, but a reprocessed surgical instrument. Therefore, MRMC studies and the concept of human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided. This is not an algorithm or AI device.
7. The type of ground truth used
- As mentioned, the concept of "ground truth" in the context of expert consensus or pathology is not applicable. The "ground truth" for this device's substantial equivalence is based on meeting engineering performance specifications, cleaning efficacy, biocompatibility standards, and sterilization validation results, all benchmarked against the original (predicate) device's validated performance and relevant regulatory standards (e.g., ISO standards for biocompatibility).
8. The sample size for the training set
- This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set. The "training" for this device would refer to the validated reprocessing procedures, not data used for an algorithm.
9. How the ground truth for the training set was established
- This information is not applicable and not provided for the reasons stated in point 8.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. In the center is a stylized design of a human figure, represented by three overlapping profiles, with a wing-like shape extending from the head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
Surgical Instrument Service and Savings Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K153258
Trade/Device Name: Medline Renewal Reprocessed Versaport V2 Bladeless Optical Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: March 7, 2016 Received: March 8, 2016
Dear Ms. Panteleon:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| ManufacturerModel No. | Description | Diameter x Length |
|---|---|---|
| ONB5STF | Optical bladeless Standard Trocar withFixation Cannula | 5- x 100-mm |
| ONB5SHF | Optical bladeless Short Trocar with FixationCannula | 5- x 70-mm |
| ONB5LGF | Optical bladeless Standard Trocar withFixation Cannula | 5- x 150-mm |
| ONBFCA5LG | Long Fixation Cannula | 5- x 150-mm |
| ONBFCA5SH | Short Fixation Cannula | 5- x 70-mm |
| ONBFCA5ST | Standard Fixation Cannula | 5- x 100-mm |
| ONB11STF | Optical bladeless Standard Trocar withFixation Cannula | 11-x 100-mm |
| ONB11LGF | Optical bladeless Long Trocar with FixationCannula | 11-x 150-mm |
| ONBFCA11ST | Standard Fixation Cannula | 11-x 100-mm |
| ONB12STF | Optical bladeless Standard Trocar withFixation Cannula | 12- x 100-mm |
| ONB12LGF | Optical bladeless Long Trocar with FixationCannula | 12- x 150-mm |
| ONB12SHF | Optical bladeless Short Trocar with FixationCannula | 12- x 70-mm |
| ONB12STS | Optical bladeless Standard Trocar withSmooth Cannula | 12- x 100-mm |
| ONBFCA12ST | Standard Fixation Cannula | 12- x 100-mm |
| ONBFCA12LG | Long Fixation Cannula | 12- x 150-mm |
Reprocessed Single-Use Device Models Included in Clearance:
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Indications for Use
510(k) Number (if known) K153258
Device Name
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar
Indications for Use (Describe)
The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the left of it. To the right of "Medline" is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
510(k) Summary K153258
| Submitter/Owner | Medline ReNewal2747 SW 6th St.Redmond, OR 97756 |
|---|---|
| Contact Name | Brandi PanteleonDirector, QA/RAP: 541-516-4180F: 541-923-3375E: bpanteleon@medline.com |
| Prepared by | Stephanie MaysTechnical WriterP: 541-516-4205F: 541-923-3375E: smays@medline.com |
| Date Prepared | November 9, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Versaport V2Bladeless Optical TrocarCommon Name: Surgical Trocar |
| Classification | Laparoscope, General & Plastic Surgery, ReprocessedProduct code: NLMClass: Class II, non-exemptClassification Number: 21 CFR § 876.1500 |
| Predicate Device | K112349 Covidien Versaport V2 Bladeless Optical Trocar (11-mm and 12-mm trocars) |
| ReferenceDevice | K130435 Covidien Versaport V2 Bladeless Optical Trocar (5-mm trocars) |
| DeviceDescription | The Medline ReNewal Reprocessed Versaport V2 Bladeless OpticalTrocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator,allows optical entry for visualization of tissue layers during insertion. It isavailable in standard (100 mm), short (70 mm) and long (150 mm) cannulalengths. The obturator housing contains a scope retention mechanism andthe trocar housing contains internal seals to prevent loss ofpneumoperitoneum when instruments are inserted into a port or withdrawncompletely from a port. The 5-mm, 11-mm and 12-mm Versaport sealsystem accommodate instruments indicated as 5-mm up to 11-mm and12-mm respectively. |
| Intended Use | The Medline ReNewal Reprocessed Versaport V2 Bladeless OpticalTrocar is intended for use in a variety of gynecologic, general, thoracic andurologic endoscopic procedures to create and maintain a port of entry. Thetrocar may be used with or without visualization for primary and secondaryinsertions. |
| TechnologicalCharacteristics | The technological characteristics and the fundamental scientifictechnology of the subject device are identical to the predicate device. Theproposed device is a reprocessed version of the predicate device. |
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Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star symbol to the right of it. To the right of the Medline logo is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" are the words "Full Circle Reprocessing" in a smaller font.
The functional characteristics of the proposed device have been evaluated and were found to be substantially equivalent to the predicate device based on the following tests:
- Simulated use and artificial soiling;
- Functional performance studies:
- Seal leakage; O
- Seal drag; O
- Surface roughness; O
- Visualization. O
- Seal leakage; O
- Cleaning:
O
.
- Protein and carbohydrates; o
- Visual inspection;
Performance Testing
- O Cleaning performance qualification.
- Biocompatibility:
- Cytotoxicity (direct and in-direct patient contacting); O
- Irritation (direct and in-direct patient contacting); O
- Sensitization (direct and in-direct patient contacting); O
- Material-mediated pyrogenicity (direct and in-direct patient O contacting); and
- Acute systemic toxicity (direct and in-direct patient O contacting).
- . Sterilization and packaging validations:
- O Bioburden enumeration testing;
- O Ethylene oxide and ethylene chlorohydrin residuals testing
- . Product stability.
| ManufacturerModel No. | Description | Diameter xLength | |
|---|---|---|---|
| Device models | ONB5STF | Optical bladeless Standard Trocarwith Fixation Cannula | 5- x 100-mm |
| ONB5SHF | Optical bladeless Short Trocar withFixation Cannula | 5- x 70-mm | |
| ONB5LGF | Optical bladeless Standard Trocarwith Fixation Cannula | 5- x 150-mm | |
| ONBFCA5LG | Long Fixation Cannula | 5- x 150-mm | |
| ONBFCA5SH | Short Fixation Cannula | 5- x 70-mm | |
| ONBFCA5ST | Standard Fixation Cannula | 5- x 100-mm | |
| ONB11STF | Optical bladeless Standard Trocarwith Fixation Cannula | 11- x 100-mm | |
| ONB11LGF | Optical bladeless Long Trocar withFixation Cannula | 11- x 150-mm | |
| ONBFCA11ST | Standard Fixation Cannula | 11- x 100-mm | |
| ONB12STF | Optical bladeless Standard Trocarwith Fixation Cannula | 12- x 100-mm | |
| ONB12LGF | Optical bladeless Long Trocar withFixation Cannula | 12- x 150-mm | |
| ONB12SHF | Optical bladeless Short Trocar withFixation Cannula | 12- x 70-mm | |
| ONB12STS | Optical bladeless Standard Trocarwith Smooth Cannula | 12- x 100-mm | |
| ONBFCA12ST | Standard Fixation Cannula | 12- x 100-mm | |
| ONBFCA12LG | Long Fixation Cannula | 12- x 150-mm |
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Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Conclusion Medline ReNewal concludes that the proposed Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is substantially equivalent to the predicate device.
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Image /page/7/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below. The logo is simple and professional, and it is likely used to promote Medline Renewal's products or services.
Predicate, Reference, and Medline ReNewal Reprocessed Covidien Versaport V2 Bladeless Optical Trocar device comparison chart.
| Predicate Device | Reference Device | Proposed Device | ComparisonAnalysis | |
|---|---|---|---|---|
| Device Characteristic | Covidien VersaportBladeless Optical Trocar | Covidien Versaport V2Bladeless Optical Trocar | Medline ReNewal VersaportBladeless Optical Trocar | |
| 510(k) Number | K112349 | K130435 | K153258 | NA |
| IntendedUse/Indications for Use | The Versaport BladelessOptical Trocar is intended foruse in a variety of gynecologic,general, thoracic and urologicendoscopic procedures tocreate and maintain a port ofentry. The trocar may be usedwith or without visualization forprimary and secondaryinsertions. | The Versaport V2 BladelessOptical Trocar is intended foruse in a variety of gynecologic,general, thoracic and urologicendoscopic procedures tocreate and maintain a port ofentry. The trocar may be usedwith or without visualization forprimary and secondaryinsertions. | The Medline ReNewalReprocessed VersaportBladeless Optical Trocar isintended for use in a variety ofgynecologic, general, thoracicand urologic endoscopicprocedures to create andmaintain a port of entry. Thetrocar may be used with orwithout visualization forprimary and secondaryinsertions. | Same |
| Design Configurationand Model | 5-mm diameter in models:ONB5STF (100 mm)ONB5SHF (70 mm)ONB5LGF (150 mm)ONBFCA5LG (150 mm)ONBFCA5SH (70 mm)ONBFCA5ST (100 mm) | NA | 5-mm diameter in models:ONB5STF (100 mm)ONB5SHF (70 mm)ONB5LGF (150 mm)ONBFCA5LG (150 mm)ONBFCA5SH (70 mm)ONBFCA5ST (100 mm) | same |
| NA | 11-mm diameter in models:ONB11STF (100 mm)ONB11LGF (150 mm)ONBFCA11ST (100 mm) | 11-mm diameter in models:ONB11STF (100 mm)ONB11LGF (150 mm)ONBFCA11ST (100 mm) | Same |
Continued
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Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it.
Predicate, Reference, and Medline ReNewal Reprocessed Covidien Versaport Bladeless Optical Trocar device comparison chart (concluded).
| Device Characteristic | Predicate Device | Reference Device | Proposed Device | ComparisonAnalysis |
|---|---|---|---|---|
| Covidien Versaport V2Bladeless Optical Trocar | Covidien Versaport V2Bladeless Optical Trocar | Medline ReNewal VersaportBladeless Optical Trocar | ||
| Design Configurationand Model (concluded) | NA | 12-mm diameter in models:ONB12STF (100 mm)ONB12LGF (150 mm)ONB12SHF (70 mm)ONB12STS (100 mm)ONBFCA12ST (100 mm)ONBFCA12LG (150 mm) | 12-mm diameter in models:ONB12STF (100 mm)ONB12LGF (150 mm)ONB12SHF (70 mm)ONB12STS (100 mm)ONBFCA12ST (100 mm)ONBFCA12LG (150 mm) | Same |
| TechnologicalCharacteristics | Transparent cannula,bladeless obturator withtransparent optical window atdistal end, obturator housingscope retention mechanismand external interlockingsnaps.Scope retention mechanism iswithin the obturator housing forsecured insertion and retentionof appropriately sized 0°laparoscope for visualization oftissue layers during insertioninto body cavity.Three-way stopcock forinsufflation and rapiddesufflation. Externalinterlocking snaps secure | Transparent cannula,bladeless obturator withtransparent optical window atdistal end, obturator housingscope retention mechanismand external interlockingsnaps.Scope retention mechanism iswithin the obturator housing forsecured insertion and retentionof appropriately sized 0°laparoscope for visualization oftissue layers during insertioninto body cavity.Three-way stopcock forinsufflation and rapiddesufflation. Externalinterlocking snaps secure | Transparent cannula,bladeless obturator withtransparent optical window atdistal end, obturator housingscope retention mechanismand external interlockingsnaps.Scope retention mechanism iswithin the obturator housing forsecured insertion and retentionof appropriately sized 0°laparoscope for visualization oftissue layers during insertioninto body cavity.Three-way stopcock forinsufflation and rapiddesufflation. Externalinterlocking snaps secure | Same |
§ 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.