The Orchestra® Hydrophilic Guidewire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Orchestra Hydrophilic Guidewire. The document states that the device is substantially equivalent to a previously cleared device (K131072) and details the nonclinical tests performed to support this claim, specifically focusing on a modification to the hydrogel coating. However, the document does not contain acceptance criteria or performance metrics that would typically be reported as "reported device performance." It also does not detail a specific "study" in the sense of a standalone algorithm or a comparative effectiveness study with human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets those criteria, as this information is not present in the provided text.

Based on the information available, here are the details related to the nonclinical testing mentioned:

1. Table of acceptance criteria and the reported device performance:
- Not provided. The document states that "all current product requirements and specifications were met" for the modified coating. However, the specific requirements and their numerical acceptance criteria are not detailed, nor are the specific performance results for each criterion.
2. Sample size used for the test set and the data provenance:
- Not provided. The document states "Bench testing was also performed by Coloplast to evaluate performance of the modified hydrophilic coating."
- The nature of the tests (e.g., durability, reliability) suggests laboratory testing, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was bench testing, not a clinical study requiring expert ground truth for interpretation of medical data.
4. Adjudication method for the test set:
- Not applicable. This was bench testing.
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:
- No. This is a medical device (guidewire), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device (guidewire), not an algorithm.
7. The type of ground truth used:
- Not applicable. The "ground truth" for bench testing would be the physical/chemical properties and functional performance measured against predefined specifications.
8. The sample size for the training set:
- Not applicable. This is bench testing for a physical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This is bench testing for a physical device, not a machine learning model.

In summary, the provided document focuses on a change to a medical guidewire's coating and confirms that the modified device continues to meet existing product requirements through bench testing. It does not provide the specific details of a study with acceptance criteria and performance data as requested in the format of a clinical or AI diagnostic study.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2015

Coloplast A/S LeeAnne Swiridow Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis. MN 55411

Re: K150927

Trade/Device Name: Orchestra Hydrophilic Guidewire Standard Angled, Orchestra Hydrophilic Guidewire Straight Stiff, Orchestra Hydrophilic Guidewire Angled Stiff, Orchestra Hydrophilic Guidewire Standard Straight Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCY Dated: March 31, 2015 Received: April 6, 2015

Dear LeeAnne Swiridow,

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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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,

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for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150927

Device Name

Orchestra® Hydrophilic guidewire standard angled, Orchestra® Hydrophilic guidewire straight stiff, Orchestra® Hydrophilic guidewire angled stiff, Orchestra® Hydrophilic guidewire standard straight, Orchestra® Hydrophilic guidewire straight stiff.

Indications for Use (Describe)

The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.

Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Ostomy Care Jrology & Continence Care Wound & Skin Care

2. 510(k) SUMMARY

510(k) Owner's Name:	Coloplast A/S
Address:	Holtedam 13050 Humlebaek, Denmark
Phone/Fax/Email:	Office:	(612) 302-4945
	Mobile:	(612) 242-4076
	Fax:	(612) 287-4138
	Email:	uslams@coloplast.com
Name of Contact Person:	LeeAnne SwiridowSr. Regulatory Affairs Specialist
Address/Contact:	1601 West River Road NMinneapolis, MN 55411
Date Prepared:	March 30th, 2015; revised May 27th, 2015
Trade Name:	Orchestra® Hydrophilic guidewire standard angledOrchestra® Hydrophilic guidewire straight stiffOrchestra® Hydrophilic guidewire angled stiffOrchestra® Hydrophilic guidewire standard straightOrchestra® Hydrophilic guidewire straight stiff
Common Name:	Hydrophilic guidewire
Classification Name:	Endoscopic Guidewire, Gastroenterology-Urology
Product code:	OCY

Description of the Device:

Intended Use of the Device:

The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourological procedures.

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Predicate Device:

The Orchestra® Hydrophilic Guidewire is substantially equivalent in performance, indication, design and materials to Orchestra® Hydrophilic Guidewire, cleared under Premarket notification # K131072.

Summary and Conclusions from the Nonclinical Tests Submitted:

Merit modified the proportion of constituents in the hydrogel coating of Merit Laureate™ Hydrophilic Guidewire to improve the level of crosslinking. This change was made to improve the durability and reliability of the coating. Since all current product requirements and specifications were met when manufactured with the new coating change, this change does not alter the form, fit or function of the product (See Merit Product Change Notification in Appendix C).

Bench testing was also performed by Coloplast to evaluate performance of the modified hydrophilic coating to ensure the product is still suitable for gastroenterology/urology use.

Conclusion

Based on the indications for use, design, technical characteristics, safety, and successfully completed performance testing, the Orchestra® Hydrophilic Guidewire is substantially equivalent to Orchestra® Hydrophilic Guidewire, cleared under Premarket notification # K131072.

Regulation Number and Section

§ 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.