(79 days)
No
The description focuses on pressure measurement and time-based monitoring for leak detection, with no mention of AI or ML algorithms.
No
The device is used to test leakage in endoscopes, which is a maintenance function, not a direct treatment or diagnosis for a patient.
No
Explanation: The device is designed to test for leaks in endoscopes, which is a maintenance function, not a diagnostic one for a patient's medical condition. It performs quality control on another medical device.
No
The device description explicitly states it is a "PENTAX Medical Auto Leakage Tester SHA-P6" and describes its function of feeding air into an endoscope and measuring pressure, which are hardware-based actions. It also mentions compatibility with "PENTAX Medical flexible endoscopes," which are physical devices.
Based on the provided information, the PENTAX Medical Auto Leakage Tester SHA-P6 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is used to perform leakage testing on flexible endoscopes, which are medical instruments, not human specimens.
- The purpose of the device is to test the integrity of the endoscope, not to diagnose or provide information about a patient's health condition.
The device is a piece of equipment used for the maintenance and proper functioning of medical devices (endoscopes), which is crucial for patient safety during procedures, but it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
The PENTAX Medical Auto Leakage Tester SHA-P6 is intended to perform leakage testing on PENTAX Medical flexible endoscopes.
Product codes
PCV
Device Description
PENTAX Medical Auto Leakage Tester SHA-P6 (Hereinafter "the Device") is intended to be used to perform leakage testing on PENTAX Medical flexible endoscopes are complex devices that consist of various mechanical, optical, and video elements that might be affected by exposure to fluid. Therefore, endoscope leak testing is a crucial procedure for the proper endoscope cleaning and disinfecting process. The Device is designed to detect leaks by measuring the difference in air pressure over time using the Automated Leak Test mode (ALT mode). The Device conducts two types of tests: a dry leakage test and a wet leakage test. The dry leakage test is performed when the device feeds air into the endoscope until a set pressure is reached, and then monitors the pressure over a specific period of time. The wet leakage test is conducted after confirming the absence of a leak during the dry leakage test, by immersing the endoscope in potable water to test for loss of integrity in its watertight construction. The Device is compatible with PENTAX Medical flexible endoscopes.
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)
The verification test was conducted to confirm that the leak detection capabilities of the Device were similar to the Predicate Device. The Endoscope Leak Tester ZUTR-10003 (K093718) was used the comparison device, which was the device used for leak detection for the Predicate Device. The Device was successfully tested for all functions, performance, and safety as per FDA Guidance and recognized consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2021
PENTAX of America, Inc. William Goeller Vice President, Ouality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K212201
Trade/Device Name: PENTAX Medical Auto Leakage Tester SHA-P6 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: PCV Dated: July 12, 2021 Received: July 14, 2021
Dear William Goeller:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212201
Device Name
PENTAX Medical Auto Leakage Tester SHA-P6
Indications for Use (Describe)
The PENTAX Medical Auto Leakage Tester SHA-P6 is intended to perform leakage testing on PENTAX Medical flexible endoscopes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
a. Applicant
PENTAX of America, Inc. 3 Paragon Drive Montvale, New Jersey 07645-1782
b. Contact/Application Correspondent
William Goeller Vice President, Quality and Regulatory Affairs PENTAX of America, Inc. 3 Paragon Drive Montvale, New Jersey 07645-1782
Phone: 201-571-2300 ext. 2318 Fax: 201-571-2340 Email: william.goeller@pentaxmedical.com
- Date Prepared: November 20, 2020 ﻦ
- d. Common Name: Leak Tester
- e. Name of the System: PENTAX Medical Auto Leakage Tester SHA-P6
- Regulation Number: 21 CFR Part 876.1500 f.
- Regulation Name: Endoscope and accessories ള.
- h. Regulatory Class: Class II
- i. Product Code: PCV
- j. Predicate Device: Automated Endoscope Leak Tester ALT-Y0003 (K123704)
- k. Reference Device: ZUTRON Medical Endoscope Leak Tester, Model ZUTR-10003 (K093718)
- Device Description: l.
PENTAX Medical Auto Leakage Tester SHA-P6 (Hereinafter "the Device") is intended to be used to perform leakage testing on PENTAX Medical flexible endoscopes are complex devices that consist of various mechanical, optical, and video elements that might be affected by exposure to fluid. Therefore, endoscope leak testing is a crucial procedure for the proper endoscope cleaning and disinfecting process. The Device is designed to detect leaks by measuring the difference in air pressure over time using the Automated Leak Test mode (ALT
4
mode). The Device conducts two types of tests: a dry leakage test and a wet leakage test. The dry leakage test is performed when the device feeds air into the endoscope until a set pressure is reached, and then monitors the pressure over a specific period of time. The wet leakage test is conducted after confirming the absence of a leak during the dry leakage test, by immersing the endoscope in potable water to test for loss of integrity in its watertight construction. The Device is compatible with PENTAX Medical flexible endoscopes.
m. Statement of Indications for Use
The PENTAX Medical Auto Leakage Tester SHA-P6 is intended to be used to perform leakage testing on PENTAX Medical flexible endoscopes.
n. Statement of Substantial Equivalence
The Device is substantially equivalent to the predicate Automated Endoscope Leak Tester ALT-Y0003 (K123704) (Hereinafter "the Predicate Device"). Both devices are used for leak testing of flexible endoscopes in combination with a connecting tube feeding air into the endoscope.
The two devices are substantially equivalent and have:
- similar Intended Use
- use the same Operating Principle ●
- incorporate the same Basic System Design
The main differences are:
- The Device only has an Automated Leak Test mode (ALT) for determining the ● watertight integrity of the endoscope.
- The Predicate Device has and Automated Leak Test mode (ALT) and A Manual Leak Test mode (MLT).
- The predicate device has additional features such as RFID tracking and internal . memory to store test results. The Device does not have these additional features.
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K212201
Page 2 of 6
o. Comparison Table
| Item | Predicate Device | Reference Device | The Device | Remark | |
|---|---|---|---|---|---|
| Product Name | Automated Endoscope Leak | ||||
| Tester | ZUTRON Medical Endoscope | ||||
| Leak Tester | PENTAX Medical Auto | ||||
| Leakage Tester | - | ||||
| Model Number | ALT-Y0003 | ZUTR-10003 | SHA-P6 | - | |
| 510(k) Number | K123704 | K093718 | N/A | - | |
| Intended Use | This equipment is intended to | ||||
| be used to perform and record | |||||
| leakage testing on Olympus | |||||
| flexible endoscopes. | The Zutron Medical ZUTR-10003 | ||||
| Endoscope Leak Tester is | |||||
| designed to detect interior and | |||||
| exterior leaks in endoscopes | This product is intended to be | ||||
| used to perform leakage | |||||
| testing on PENTAX Medical | |||||
| flexible endoscopes. | Similar *1 | ||||
| AC adapter | DC output | ||||
| voltage/current | 45 VA | 12V, 3.3A | 7.5 V, 1.6 A | Similar | |
| AC input | |||||
| frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | Identical | |
| AC input | |||||
| voltage | 100 - 120 V | 100 - 240 V | 100 - 240 V | Similar | |
| Built - in | |||||
| packaged | |||||
| lithium | |||||
| battery | Battery | ||||
| capacity | N/A | N/A | 2,600 mAh | Different *2 | |
| Size | 280 mm (W) x 201 mm (H) x | ||||
| 184 mm (D) | |||||
| 11.0 in (W) x 7.9 in (H) x 7.2 | |||||
| in (D) | 127 mm (W) x 88.9 mm (H) x | ||||
| 196.85 mm (D) | |||||
| 5.00 in (W) x 3.5 in (H) x 7.75 in | |||||
| (D | 154 mm (W) x 63.2 mm (H) x | ||||
| 95.6 mm (D) | |||||
| 6.06 in (W) x2.49 in (H) x | |||||
| 3.76 in (D) | Similar | ||||
| Weight | 5.5 kg (12.1 lbs.) | 1.4 kg (3.10 lbs.) (main unit only) | 380 g (0.84 lbs.) (main unit | ||
| only) | Different *3 | ||||
| Page 4 of 6 | |||||
| Item | Predicate Device | Reference Device | The Device | Remark | |
| Automated Leakage Testing | |||||
| (ALT) | Yes | Yes | Yes | Identical | |
| Manual Leakage Testing | |||||
| (MLT) | Yes | No | No | Different *4 |
6
K212201
7
Page 5 of 6
The following are explanations regarding the differences between the subject and predicate devices:
*1 Intended use
Intended use of the Device is similar to the Predicate Device regarding leakage testing for the flexible endoscopes.
*2 Built - in packaged lithium batterv
The availability of the built - in packaged lithium battery is a minor addition and does not raise and safety and effectiveness concerns.
*3 Weight
This is due to the difference of mechanical constructions, which does not raise any safety and effectiveness concerns.
*4 Manual Leakage Testing (MLT)
The Device only has an Automated Leakage Testing (ALT) mode. The availability of the Manual Leakage Testing (MLT) in the Predicate Device is a minor functional difference and does not raise and safety and effectiveness concerns.
Comparison to the Reference device:
ZUTRON Medical Endoscope Leak Tester, ZUTR-10003 (K093718) was selected as a Reference device due to the fact that it was used as one of the predicate devices for the premarket notification application of the Automated Endoscope Leak Tester ALT-Y0003 (K123704), which is the Predicate Device under this premarket notification of the Device.
The Reference device, ZUTRON Medical Endoscope Leak Tester, ZUTR-10003 (K093718) has been used for leakage detection testing, where both subject and predicate devices were compared in their ability to find leakage within compatible endoscopes. Subject device has been found to be substantially equivalent to the Reference device in its ability to detect leaks.
p. Software
Software verification and validation tests were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. See Section 19 Software for details.
Cybersecurity risks have been assessed according to the FDA Guidance for Industry and Staff "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued October 2, 2014. No cyber security risks have been detected since the Device has no other interface than an air feeding tube to an endoscope tested.
8
q. EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the Device were confirmed by the following standards:
IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012
r. Performance Testing
The verification test was conducted to confirm that the leak detection capabilities of the Device were similar to the Predicate Device. The Endoscope Leak Tester ZUTR-10003 (K093718) was used the comparison device, which was the device used for leak detection for the Predicate Device. The Device was successfully tested for all functions, performance, and safety as per FDA Guidance and recognized consensus standards.
s. Conclusion
After analyzing the intended use, technological characteristics (including operating principle, performance characteristics and constituent materials), and labeling, the Device did not raise any issue regarding safety and effectiveness. Accordingly, the testing concluded that the Device is substantially equivalent to the Predicate Device and the Reference Device.