(22 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and bench testing of a guide wire, with no mention of AI or ML technologies.
No
The device is a guide wire, which facilitates the placement of other therapeutic devices (balloon dilatation catheters) but does not directly perform a therapeutic function itself.
No
The device description and intended use clearly state that it is a guide wire used to facilitate the placement of balloon dilatation catheters, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical guide wire constructed from stainless steel with various coatings and a radiopaque tip, indicating it is a hardware medical device.
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 placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA)." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description details a physical guide wire designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is clearly used in vivo to assist in a surgical procedure.
N/A
Intended Use / Indications for Use
The JoWire Asahi PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Asahi PTCA Guide Wires are not to be in the cerebral blood vessel.
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The JoWire Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from stainless steel core wire with varying core lengths and diameters for each design. The core wire and core are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and biocompatibility testing were conducted according to the recommendations from relevant guidances to demonstrate that the JoWire Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.
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.
JoWire Asahi PTCA Guide Wire (K022762)
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
| April 2002 | MAY 14 2003 | Special 510(k) | K031277 |
|---|---|---|---|
| 510K) Summary of Safety and Effectiveness | |||
| Date Prepared: | April 21, 2003 | ||
| Submitted by: | Jomed Inc. | ||
| 2870 Kilgore Rd. | |||
| Rancho Cordova, CA 95670 | |||
| Contact Person: | Terry Schultz | ||
| Regulatory Affairs Manager | |||
| Phone Number: | (858) 673-0189 Ext. 286 | ||
| Fax Number: | (858) 673-3837 | ||
| Device Trade Name: | JoWire Asahi PTCA Guide Wire | ||
| Device Classification | |||
| Name and Class: | Catheter Guide Wire, Class II (21 CFR 870.1330) | ||
| Predicate Devices: | JoWire Asahi PTCA Guide Wire (K022762) |
MAY 1 4 2003
JoWire Asahi PTCA Guide Wires
Special 510(k)
Device Description:
Jomed Inc.
April 2002
The JoWire Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from stainless steel core wire with varying core lengths and diameters for each design. The core wire and core are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.
Intended Use:
The JoWire Asahi PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Asahi PTCA Guide Wires are not to be in the cerebral blood vessel.
Device Technological Characteristics and Comparison to Predicate Device:
The JoWire Asahi PTCA Guide Wires are made of the same materials, available in the same diameters, have a similar design, and have the same indications for use as the predicate devices and other currently marketed PTCA Guide Wires.
1
510(k) Summary (cont'd)
Performance Data:
Bench and biocompatibility testing were conducted according to the recommendations from relevant guidances to demonstrate that the JoWire Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.
Conclusion:
The JoWire Asahi PTCA Guide Wires are substantially equivalent to the claimed predicate devices and other currently marketed PTCA Guide Wires.
14031277 Premarket Notification [510(k)] Number
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle head facing left, with three parallel lines extending from the back of the head, representing the agency's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2003
Ms. Terry Schultz Regulatory Affairs Manager JOMED. Inc. 15330 Avenue of Science, Suite 200 San Diego CA 92128
Re: K031277
Trade Name: JoWire Asahi PTCA Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 21, 2003 Received: April 22, 2003
Dear Ms. Schultz:
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 (PMA), 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
3
Page 2 - Ms. Terry Schultz
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
.
Bram D. Zuckerman, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Jomed Inc. April 2003 JoWire Asahi PTCA Guide Wires Special 510(k)
510(k) Number (if known): ___ K 031277
Device Name: JoWire Asahi PTCA Guide Wires
Indications for Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.
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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.19)
Over-the Counter Use __________________________________________________________________________________________________________________________________________________________________________
Division Sign-Off) 510(k) N