The Orchestra® Hydrophilic Guide Wire 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 the 510(k) summary for the Coloplast Orchestra® Hydrophilic Guidewire, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria through an AI-based system.

Therefore, the information requested about acceptance criteria, device performance from an AI study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text, as this device submission is for a physical medical product, not an AI/ML-driven solution.

The document states:

Device Description: The Orchestra® Hydrophilic Guidewire is a metallic core wire with a polymer coating and a hydrophilic coating over a radiopaque polymer jacket, supplied sterile and non-pyrogenic.
Intended Use: To facilitate the placement of devices through the urinary tract during endourological procedures.
Predicate Device: Radifocus® Guidewire M from Terumo Medical Corp (K923607).
Nonclinical Tests: Product performance testing compared the subject device to the predicate device and included: visual control, dimensional test, tensile test on guidewire, flexibility test for guidewire, X-rays opacity test, guidewire fracture test, guidewire flexibility damage resistance test, and oxidation test, and friction test.

Key takeaway regarding your request:
The document does not include information about AI/ML models, their acceptance criteria, performance metrics (like sensitivity, specificity), study designs for AI evaluation, sample sizes for AI testing or training, expert adjudication, or MRMC studies because the device in question is a physical guidewire, not an AI software. The "study" mentioned is a series of non-clinical, physical performance tests comparing the new device to a predicate device to establish substantial equivalence.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Coloplast. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is divided into two halves, with the top half containing horizontal lines and the bottom half being solid black. The word "Coloplast" is written in a bold, sans-serif font.

Ostomy Care Urology & Continence Care Wound & Skin Care

K131072

3. 510(k) SUMMARY

page 1 of 2

510(k) Owner's Name:	Coloplast A/S	JUL 0 9 2013
Address:	Holtedam 13050 Humlebaek, Denmark
Phone/Fax/Email:	Office: (612) 302-4987Mobile: (612) 968-9567Fax: (612) 287-4138Email: usbes@coloplast.com
Name of Contact Person:	Brian E. SchmidtRegulatory Affairs Manager
Address/Contact:	1601 West River Road NMinneapolis, MN 55411
Date Prepared:	April 15th, 2013
Trade Name:	Orchestra® Hydrophilic Guidewire
Common Name:	Hydrophilic guidewire
Classification Name:	Endoscopic Guidewire, Gastroenterology-Urology
Product code:	OCY

Description of the Device:

Intended Use of the Device:

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

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the Coloplast logo. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is divided into two halves, with the top half containing horizontal lines and the bottom half being solid black. The word "Coloplast" is written in a bold, sans-serif font.

K131072 page 2 of 2

Predicate Device:

The Orchestra® Hydrophilic Guidewires are substantially equivalent in performance, indication, design and materials to Radifocus® Guidewire M from Terumo Medical Corp, cleared under Premarket notification # K923607.

Summary and Conclusions from the Nonclinical Tests Submitted:

Product performance testing comparing the subject device to the predicate device included the following tests/analysis: visual control, dimensional test, tensile test on guidewire, flexibility test for guidewire, X-rays opacity test, guidewire fracture test, guidewire flexibility damage resistance test, oxidation test, friction test.

Conclusion

Based on the indications for use, design, technical charcteristics, safety, and successfully completed performance testing, the Orchestra® Hydrophilic Guidewires are substantially equivalent to Radifocus® Guidewire M from Terumo Medical Corp, cleared under Premarket notification # K923607.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.

Public Health Service

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

July 9, 2013

Coloplast Corp. % Mr. Brian E. Schmidt Regulatory Affairs Manager . 1601 West River Road N MINNEAPOLIS MN 55411

Re: K131072

Trade/Device Name: Orchestra hydrophilic guidewire standard angled, orchestra hydrophilic guidewire straight stiff, orchestra hydrophilic Regulation Number: 21 CFR 876.1500 Regulation Name: Hydrophilic Guidewire Regulatory Class: Class II Product Code: OCY Dated: April 15, 2013 Received: April 17, 2013

Dear Mr. Schmidt:

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

{3}------------------------------------------------

Page 2 - Mr. Brian E. Schmidt

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Elaine H. Blyskun -S

for

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Coloplast logo. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is divided into two halves, with the top half containing horizontal lines and the bottom half being solid black. The word "Coloplast" is written in a bold, sans-serif font.

Oncare Con-Include & Continenters Car Wound & Stin Care

2. INDICATIONS FOR USE STATEMENT

Indications for Use

K131072 510(k) Number (if known):

Device Name:

Orchestra® Hydrophilic Guidewire

Indications for Use:

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

Prescription Use Counter Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elaine H. Blyskun -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131072 510(k) Number

510(k) Orchestra Hydrophilic Guidewire

Page 22 of 172

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.