(23 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of AI or ML technologies.
No
The device, a guidewire, is intended to facilitate the introduction of other diagnostic and treatment devices, not to directly treat a condition. It is an accessory device rather than a therapeutic one itself.
No
Explanation: The device, a guidewire, is described as facilitating the introduction of other diagnostic and treatment devices. It does not state that the guidewire itself performs a diagnostic function.
No
The device description clearly describes a physical guidewire made of Nitinol or Stainless Steel with a coil, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures." This describes a device used during a medical procedure to aid in the delivery of other tools, not a device used to perform a diagnostic test on a sample taken from the body.
- Device Description: The description details a physical guidewire used for navigation within the body. This is consistent with a surgical or procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This guidewire does not fit that definition.
N/A
Intended Use / Indications for Use
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
Product codes
OCY
Device Description
The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The PREDICATE™ III GUIDEWIRE family is bound by the following parameters:
Lengths: 30cm – 500cm
Outside Diameter: 0.018" to 0.038"
Tips: Straight or Shaped with various flexibilities
Coil Length: Full length, 2cm to 30cm
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
Bench testing was performed including Dimensional, Corrosion, Guidewire Pull Test, Camber Resistance, Visual Inspection Wire Fracture Test, Wire Flex Test, ISO Strength of Union, and Particulate Residue Test. Biocompatibility testing included Cytotoxicity, Chemical Characterization, and Hemolysis.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
Lake Region Medical Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Dr. Chaska, Minnesota 55318
Re: K142397
Trade/Device Name: Predicate III Guidewire Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCY Dated: August 26, 2014 Received: August 27, 2014
Dear Mathew Pexa,
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 (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
1
the quality systems (OS) 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,
Herbert P. Lerner -S
for Benjamin Fisher 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 STATEMENT
510(k) NUMBER (IF KNOWN): K142397
device name: PREDICATE™ III GUIDEWIRE
INDICATIONS FOR USE:
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
PRESCRIPTION
USE
×
AND/OR
OVER-THE-COUNTER USE
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE 1 of
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Lake Region
Medical
SECTION 2.0 - 510(k) SUMMARY
August 26, 2014
This summary is being included in the Premarket Notification submission in lieu of a statement of availability.
| 2.1 MANUFACTURER / REGISTRATION INFORMATION | ||||
|---|---|---|---|---|
| Lake Region Medical | Telephone: | 952-448-5111 | ||
| 340 Lake Hazeltine Dr. | Fax: | 952-448-3441 | ||
| Chaska, Mn 55318 | Contact Person: | Sze Yuen Tan | ||
| FDA REGISTRATION NUMBER: 2126666 | Title: | Regulatory Intern | ||
| 2.2 DEVICE TRADE NAME / PROPRIETARY NAME | ||||
| PREDICATE™ III GUIDEWIRE | ||||
| 2.3 | DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES | |||
| ENDOSCOPE AND ACCESSORIES (OCY); 21 CFR Part 876.1500 | ||||
| 2.4 | CLASS OF DEVICE | |||
| These devices are Class II. | ||||
| 2.5 | IDENTIFICATION OF PREDICATE DEVICE(S) | |||
| K011084 | Mandrel Guidewires (Lake Region Medical) | |||
| K140482 | Mandrel Guidewires (Lake Region Medical) |
DEVICE DESCRIPTION 2.6 The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of
Stainless Steel. The guidewire may contain proximal markers. The PREDICATE™ III GUIDEWIRE family is bound by the following parameters:
| Lengths: | 30cm – 500cm |
|---|---|
| Outside Diameter: | 0.018" to 0.038" |
| Tips: | Straight or Shaped with various flexibilities |
| Coil Length: | Full length, 2cm to 30cm |
2.7 COMPLIANCE WITH APPLICABLE STANDARDS
LRM has determined that no mandatory standards, performance standards, or special controls have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic or by any subsequent regulatory action. However, the following standards are referenced within this filing: ISO 10993, ISO 11070, ISO 11135, ISO 11138.
INTENDED USE STATEMENT 2.8
To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
NOTE: This modification does not alter its intended use.
CONTRAINDICATIONS 2.9
There are no contraindications listed.
2.10 TECHNOLOGICAL CHARACTERISTICS
The design specifications are substantially equivalent to the existing Mandrel Guidewires.
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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Healthcare. The logo consists of a red circular symbol with a line running through it, followed by the words "Lake Region" in a bold, sans-serif font. Below "Lake Region" is the word "Medical" in a smaller font.
2.11 QUALITY SYSTEM CONTROL
DESIGN CONTROLS
LRM is in conformance with the design control procedure requirements as specified in 21 CFR Part 820.33. Risk analysis was completed by means of a Failure Mode and Effects Analysis and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.
MATERIALS / SUPPLIER / PRODUCT / PROCESS CONTROLS
LRM has formal quality systems in placed to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse effect on safety or effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size / group.
2.12 QUALIFICATION TESTING
The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device.
BENCH TESTING
●
●
●
In order to demonstrate equivalence of the guidewire, Lake Region Medical performed bench testing to establish requirements. Test devices were manufactured and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. The devices were then subjected to the following test methods to show the devices comply with the design input summary:
- Dimensional
- Corrosion
- Guidewire Pull Test ●
- Camber Resistance
- Visual Inspection Wire Fracture Test
- · Wire Flex Test
- · ISO Strength of Union
- Particulate Residue Test
BIOCOMPATIBILITY TESTING
Biocompatibility testing per the design input summary requirements show the addition of full length coil to the device does not affect the biocompatibility of the device is still in compliance with pre-defined acceptance criteria outlined in the product Design Input Summary. A biocompatibility risk assessment determined the following biocompatibility tests are required:
- Cytotoxicity
- Chemical Characterization
Hemolysis SUBSTANTIAL EQUIVALENCE DATA 2.13
The addition of full length coil to the Mandrel guidewire family does not change the indications for use of the Mandrel guidewires and is not a change to the fundamental scientific technology. The information summarized above shows the device will perform as well as the previously marketed device.