(78 days)
K942677, 510(k) number unknown
Not Found
No
The description focuses on the physical construction and mechanical properties of a guidewire, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is used to guide and exchange other endoscopic and electrosurgical devices, making it an accessory rather than a therapeutic device itself.
No
The device description indicates it is a guidewire used to guide other devices, and the intended use specifies it for selective cannulation of biliary ducts, which are procedural actions, not diagnostic ones.
No
The device description clearly details physical components like a nitinol core wire, shrink jacket, radiopaque tube, and ink bands, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. This is a procedural device used within the body, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details the physical construction of a guidewire, which is a tool used in medical procedures. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
This device is a medical device used in interventional procedures, specifically in the biliary system.
N/A
Intended Use / Indications for Use
The Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.
Product codes (comma separated list FDA assigned to the subject device)
OCY, GCA
Device Description
Radius Medical Technologies, Inc. has developed a line of Endoscopic guidewires ranging in sizes of 0.025" to 0.035" diameter and lengths of 260 cm to 450 cm (in standard and stiff body types). The wires will be offered with a 5 cm radiopaque distal tip (angled and straight). The wires are constructed of a solid nitinol core wire, which tapers at its distal end. A shrink jacket surrounds the core over the entire length except the distal most 5 cm. A radiopaque tube covers the distal 5 cm. Single striped bands of ink are placed circumferentially onto the jacket and spaced in 1 cm intervals beginning at the 6 cm location and continuing to the 40 cm location from the distal tip. Multiple ink bands are used to delineate the 10, 15, and 20 cm locations. A coating is applied over the tip portion of the guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary ducts, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.
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)
Testing on the Next Generation Guidewire includes distal tip tensile, torqueability, tip flexibility, coating adherence/integrity, and electrical resistance (in accordance with AAMI HF 18).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K942677, 510(k) number unknown
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Radius Medical Technologies, Inc. Maureen A. Finlayson President 63 Great Road Maynard, MA 01754
Re: K011759
Trade/Device Name: Radius Medical Technologies Next Generation Guidewire Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY, GCA Dated (Date on orig SE Itr): June 1, 2001 Received (Date on orig SE Itr): June 6, 2001
JUL 2 7 2015
Dear Ms. Finlayson,
This letter corrects our substantially equivalent letter of August 23, 2001.
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
1
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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
Page 10
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Radius Medical Technologies Next Generation Guidewire Device Name:
Indications For Use:
The Next Generation Guidewire is designed to be used to guide and exchange endoscopic The Next Ochenation Outcomers for biliary procedures. The guidewire is indicated accessories and cloudsurgied. dot: too iccs, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
Nancy C Brogdon
Division Sign Off
OR
(Division Sign Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K01/759
3
AUG 2 3 2001
011759 Page 1 of 2
510(k) Summary of Safety and Effectiveness
Sponsor Name 1.
Radius Medical Technologies, Inc. 63 Great Road Maynard, MA 01754 Telephone: 978 897 6469 Contact Individual: Debbie Iampietro
Device Name 2.
Proprietary Name: Next Generation Guidewire Common/Usual Name: Guidewire Classification Name: Endoscope and accessory
Identification of Predicate or Legally Marketed Device 3.
The Next Generation Guidewire is substantially equivalent to the Microvasive Geenen Endotorque Guidewire (K942677) Boston Scientific Microvasive Jagwire (510(k) number unknown)
Device Description 4.
Radius Medical Technologies, Inc. has developed a line of Endoscopic guidewires ranging in sizes of 0.025" to 0.035" diameter and lengths of 260 cm to 450 cm (in standard and stiff body types). The wires will be offered with a 5 cm radiopaque distal tip (angled and straight). The wires are constructed of a solid nitinol core wire, which tapers at its distal end. A shrink jacket surrounds the core over the entire length except the distal most 5 cm. A radiopaque tube covers the distal 5 cm. Single striped bands of ink are placed circumferentially onto the jacket and spaced in 1 cm intervals beginning at the 6 cm location and continuing to the 40 cm location from the distal tip. Multiple ink bands are used to delineate the 10, 15, and 20 cm locations. A coating is applied over the tip portion of the guidewire.
5, Intended Use
The Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.
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Page 55
K 011759 Page 207
- Comparison of Technological Characteristics 6.
The Next Generation Guidewire is substantially equivalent to the Boston Scientific Microvasive Jagwire and the Microvasive Geenen Endotorque Guidewire. The Radius Medical Next Generation Guidewire is substantially equivalent to the predicate devices listed, which provide the same or similar functions. The intended use and technological characteristics including, design, materials and method of operation support the concept of substantial equivalence.
Performance Testing 7
Testing on the Next Generation Guidewire includes distal tip tensile, torqueability, tip flexibility, coating adherence/integrity, and electrical resistance (in accordance with AAMI HF 18).