(51 days)
Not Found
No
The summary describes a physical guidewire with a hydrophilic coating and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device facilitates the placement of other devices and does not directly treat a disease or condition. Its function is to aid in a procedure, not to be a therapy itself.
No
The device description and intended use indicate it is a guidewire used to facilitate the placement of other devices during procedures, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it is a "metallic core wire with a polymer coating" and a "hydrophilic coating," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "hydrophilic guidewire" intended to "facilitate the placement of devices through the urinary tract during endourologic procedures." This describes a device used within the body for a procedural purpose, not for testing samples.
The information provided aligns with a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.
Product codes
OCY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
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
1
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,
Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a simple, sans-serif font. The text is arranged horizontally, with the name "Herbert P. Lerner" followed by a hyphen and the letter "S". The text is black and the background is white. The text is clear and easy to read.
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Coloplast. The logo consists of a blue circle on the left side with horizontal lines across the top half. To the right of the circle is the word "Coloplast" in a bold, blue font.
Ostomy Care Jrology & Continence Care Wound & Skin Care
2. 510(k) SUMMARY
| 510(k) Owner's Name: | Coloplast A/S | ||
|---|---|---|---|
| Address: | Holtedam 1 | ||
| 3050 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 Swiridow | ||
| Sr. Regulatory Affairs Specialist | |||
| Address/Contact: | 1601 West River Road N | ||
| Minneapolis, MN 55411 | |||
| Date Prepared: | March 30th, 2015; revised May 27th, 2015 | ||
| Trade 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 | |||
| Common Name: | Hydrophilic guidewire | ||
| Classification Name: | Endoscopic Guidewire, Gastroenterology-Urology | ||
| Product code: | OCY |
Description of the Device:
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.
Intended Use of the Device:
The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourological procedures.
4
Image /page/4/Picture/0 description: The image shows the logo for Coloplast. The logo consists of a blue circle on the left side with horizontal lines across the top half. To the right of the circle is the word "Coloplast" in a bold, blue font.
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.