(118 days)
Not Found
No
The description focuses on the physical construction and materials of the guide wire, with no mention of AI or ML capabilities. The performance studies are limited to bench and biocompatibility testing, not algorithmic performance.
No
The device is a guide wire intended to facilitate the placement of other catheters, not to provide therapy itself.
No
Explanation: The device, a guide wire, is used to facilitate the placement of balloon dilatation catheters. Its function is to aid in a medical procedure (PTCA/PTA), not to diagnose a condition or provide diagnostic information.
No
The device description clearly details physical components such as a stainless steel core wire, coil, radiopaque tip, and various coatings, indicating it is a physical medical 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a guide wire used within the body to facilitate the placement of catheters during angioplasty procedures. It is a tool used in a surgical/interventional procedure, not for analyzing samples outside the body.
The information provided describes a device used in vivo (within a living organism), not in vitro (in glass, referring to laboratory testing).
N/A
Intended Use / Indications for Use
The JoWire Neo's PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheter 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
DQX
Device Description
The JoWire Neo's PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 180 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire with varying core lengths and diameters for each design. The core wire and coil 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
coronary, peripheral (not cerebral blood vessel)
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 FDA guidance to demonstrate that the JoWire Neo's 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)
Hi Torque Floppy® Guide Wire (K974773), Hi Torque Cross IT TM Guide Wire (K990639)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KC22762
DEC 1 6 2002
JOMED Inc. August 2002 JoWire PTCA Guide Wires Traditional 510(k)
510K) Summary of Safety and Effectiveness
| Date Prepared: | August 19, 2002 |
|---|---|
| Submitted by: | JOMED Inc. |
| Contact Person: | Terry Schultz |
| Regulatory Affairs Manager | |
| Phone Number: | (858) 673-0189 Ext 286 |
| Fax Number: | (858) 673-3837 |
| Device Trade Name: | JoWire Neo's PTCA Guide Wire |
| Classification Name: | Catheter guide wire (21 CFR 870.1330) |
| Predicate Device: | Hi Torque Floppy® Guide Wire (K974773) |
| Hi Torque Cross IT TM Guide Wire (K990639) |
Device Description:
The JoWire Neo's PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 180 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire with varying core lengths and diameters for each design. The core wire and coil 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 Neo's PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheter 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.
Device Technological Characteristics and Comparison to Predicate Device:
The JoWire Neo's PTCA Guide Wires are made of similar materials, are available in similar diameters and lengths, have a similar design, and the same indications for use as the predicate devices and other currently marketed PTCA Guide Wires.
33
1
022762
JOMED Inc. August 2002 JoWire PTCA Guide Wires Traditional 510(k)
Performance Data:
Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the JoWire Neo's 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 Neo's PTCA Guide Wires are substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.
KO22762
Premarket Notification [510(k)] Number
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human figures connected at the shoulders, with their heads tilted forward.
Public Health Service
DEC 1 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JOMED Inc. Ms. Terry Schultz Regulatory Affairs Manager 15330 Avenue of Science, Suite 200 San Diego, CA 92128
K022762 Re:
Trade Name: JoWire Neo's PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: December 3. 2002 Received: December 4, 2002
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. Iisting 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 vour 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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
OCT 11th
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
JOMED Inc. August 2002
JoWire PTCA Guide Wires Traditional 510(k)
4022762 510(k) Number (if known):
Device Name: JoWire Neo's 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.
(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 801.19)
OR
Over-the Counter
Usc
NCeRTCh
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number.
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