(54 days)
The Nipro Hydrophilic Guidewires are designed for use in urological, laparoscopic, and radiological procedures where a smooth guidewire is desired to introduce/position catheters, direct and maintain access, and be used to guide and exchange endoscopic accessories.
The subject devices is contructed from a superelastic Nitinal core wire. A plastic cladding is applied over the core with a hydrophilic coating applied over that to provide a virtually frictionless surface when wet. The polymer cladding is impregnated with a radiopacive agent for enhanced contrast under fluoroscopy.
The provided text describes a 510(k) premarket notification for a medical device, the Nipro Hydrophilic Guidewire. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new standalone clinical study to prove effectiveness. Therefore, many of the requested elements for a study proving device acceptance criteria are not directly applicable or explicitly stated in this document.
However, I can extract the information relevant to the substantial equivalence comparison and performance testing that demonstrates the device meets certain criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the Nipro Hydrophilic Guidewire is either identical or very similar to predicate devices in materials, design, technological characteristics, and indications for use. It claims that "Performance, voluntary standards, and biocompatibility tests demonstrate that the devices are substantially equivalent." While specific quantitative acceptance criteria are not detailed in this summary, the general criterion is "Substantial Equivalence" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Materials, design, technological characteristics, and indications for use are identical or very similar to predicate devices. | The Nipro subject device is either identical (K001251) or very similar to the predicate devices materials, design and technological characteristics, and indications for use. |
| Performance: Meets the performance characteristics demonstrated by predicate devices. | Performance tests demonstrate that the devices are substantially equivalent. |
| Voluntary Standards: Complies with relevant voluntary standards. | Voluntary standards tests demonstrate that the devices are substantially equivalent. |
| Biocompatibility: Safe for biological contact as per established standards. | Biocompatibility tests demonstrate that the devices are substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of a prospective clinical study with human patients for this 510(k) submission. The evaluation is based on comparisons to predicate devices and likely bench testing and biocompatibility assessments. Therefore, "sample size" and "data provenance" in the clinical study sense are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for a 510(k) relies on regulatory standards, established predicate device performance, and laboratory/biocompatibility testing, not expert consensus on a clinical test set.
4. Adjudication Method for the Test Set
Not applicable for a 510(k) submission based on substantial equivalence and non-clinical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. This type of study is typically used for diagnostic devices to compare human reader performance with and without AI assistance, which is outside the scope of demonstrating substantial equivalence for a guidewire.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this refers to a medical device (guidewire) and not an algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by:
- Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate devices (Nipro Hydrophilic Guidewire (K001251) and Terumo Medical Corporation RadiFocus Guidewire (K926214, K923607)).
- Voluntary Standards: Adherence to recognized industry standards for guidewires.
- Biocompatibility Testing: Results of laboratory tests confirming material safety.
- Performance Testing: Bench-top testing to verify physical and functional properties deemed equivalent to the predicate.
8. The Sample Size for the Training Set
Not applicable. This device is a physical guidewire and would not have a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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Ko 60034
Image /page/0/Picture/1 description: The image shows the logo for Nipro Corporation. The logo consists of a stylized, abstract symbol on the left, resembling two intertwined ribbons or a stylized letter 'N'. To the right of the symbol is the company name, 'NIPRO', in a bold, sans-serif typeface. The entire logo is rendered in black against a white background.
3150 N.W. 107 Avenue Miami. Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
FEB 2 8 2006
SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO HYDROPHILIC GUIDEWIRE
807.92 (a)(1)
Contact Person:
Date of Summary Preparation:
Luis Candelario President February 16, 2006
807.92 (a)(2)
Trade Name: Common Name: Classification Name:
Nipro Hydrophilic Guidewire Guidewire for Urological and Laparoscopic Use Endoscope and Accessories (21 CFR 876.1500) Crological Catheter and Accessories (21 CFR 876.5130) 70
Panel:
807.92 (a)(3)
Legally Marketed Substantially Equivalent Device:
Ninro Hydrophilic Guidewire (K001251)
Terumo Medical Corporation RadiFocus Guidewire (K926214, K923607)
807.92 (a)(4)
Description of Device:
The subject devices is contructed from a superelastic Nitinal core wire. A plastic cladding is applied over the core with a hydrophilic coating applied over that to provide a virtually frictionless surface when wet. The polymer cladding is impregnated with a radiopacive agent for enhanced contrast under fluoroscopy.
807.92 (a)(5)
Intended Use: The Nipro Hydrophilic Chidewires are designed for use in urological, laparoscopic, and radiological procedures where a smooth guidewire is desired to introduce/position cathers, direct and maintain access and be used to guide and exchange endoscopic accessories.
807.92 (a)(6)
Comparison of Technical Characteristics:
The Nipro subject device is either identical (K001251) or very similar to the predicate devices materials, design and technological characteristics, and indications for use. Performance, voluntary standards, and biocompatibility tests demonstrate that the devices are substantially equivalent.
Nipro Hydrophilic Guidewire for Urological and Laparoscopic Use
510(k) Amendment
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2006
Nipro Medical Corporation % Kaelyn B. Hadley, Ph.D. Consultant 1384 Copperfield Court LEXINGTON KY 40514
Re: K060034 Trade/Device Name: Nipro Hydrophilic Guidewire for Urological and Laparoscopic Use Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: January 5, 2006 Received: January 5, 2006
Dear Dr. Hadley:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow Jours of substantial equivalence of your device to a legally premarket notheating "The sification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific active for your as one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, produse note the regulation on your responsibilities under the Act from the 607.77). I ou may octurers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Brigdon
Nanev C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060034
Device Name: Nipro Hydrophilic Guidewire for Urological and Laparoscopic Use
Indications For Use: The Nipro Hydrophilic Guidewires are designed for use in urological, laparoscopic, and radiological proccdures where a smooth guidewire is desired to introduce/position catheters, direct and maintain access, and be used to guide and exchange endoscopic accessories.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDLED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nipro Hydrophilic Guidewire for Urological and Laparoscopic Use
510(k) Amendment
Nancy Hodgson
(Division Sign-Off)
Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.
§ 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.