(30 days)
Not Found
No
The document describes a pressure measurement system and guide wire. There is no mention of AI or ML in the intended use, device description, or performance studies. The "intelligence" mentioned in the Patient Cable description refers to circuitry setup, not AI/ML.
No
The device measures blood pressure and facilitates the placement of other interventional devices for diagnostic and interventional procedures, but it does not directly treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use... to measure blood pressure during diagnostic and/or interventional procedures" and that "Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease." This clearly indicates a diagnostic purpose.
No
The device description clearly outlines hardware components: the SmartWire (a physical guide wire with a pressure sensor) and the SmartMap (an interface unit). While software is likely involved in processing the pressure data, the core of the system includes physical medical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SmartWire/SmartMap Pressure System is designed to measure blood pressure directly within the coronary and peripheral arteries and other blood vessels. This is an in vivo measurement (within the living body), not an in vitro measurement (outside the living body).
- Intended Use: The intended use clearly states it's for measuring blood pressure during diagnostic and/or interventional procedures within the blood vessels.
- Device Description: The description details a guide wire with a pressure sensor and an interface system to connect to hemodynamic monitors. This aligns with an in vivo pressure measurement system.
Therefore, the SmartWire/SmartMap Pressure System is an in vivo diagnostic and interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SmartWire/SmartMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The SmartWire can also be used in replacement of an angioplasty guide wire to facilitate the placement of a balloon dilation catheter, as well as other interventional devices. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, I he Sinal White Smarthup Fressure Byoss to measures blood pressure during diagnostic angiography and/or interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
74 DQX, DXD
Device Description
The Jometrics SmartWire/SmartMap Pressure System consists of the SmartWire and the SmartMap. Additionally, the SmartWire can be used with the existing WaveMap with the inclusion of the Patient Cable Model 8000.
The SmartWire is a steerable pressure monitoring guide wire used to obtain intracoronary pressure measurements before, during, and after interventional procedures. There are two lengths. 189 cm and 300 cm and the outside diameter is .014". The screw tip, core wire, proximal coil and hypotube are manufactured from stainless steel. The tip coil is composed of a platinum, iridium alloy and coated to provide lubricity. The hypotube and proximal coil are also coated to provide lubricity.
The SmartMap is designed to interface a SmartWire Pressure Wire to the auxiliary input of hemodynamic (Physio Monitor) systems. The SmartMap's power is derived from the hemodynamic system and provides in return an industry standard (AAMI BP22-2-1994) 5uV/V/mmHg output back to the hemodynamic system.
The instrument is intended to measure pressure from a pressure sensor on a guide wire in the coronary and peripheral vasculature during diagnostic and/or interventional procedures.
The Patient Cable Model 8000 is a preamplifier/signal condition unit designed to interface the SmartWire family of wires to an existing WaveMap Instrument. It uses intelligence to set up the circuitry designed to process the SmartWire as done in the SmartMap so that SmartWires may be used with either the SmartMap or the WaveMap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and peripheral arteries / all blood vessels
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)
Applicable testing was performed to evaluate the changes in the SmartWire/SmartMap Pressure System. The testing results were found to be comparable to those of the predicate device, the WaveWire/WaveMap Pressure System. All new materials were tested for biocompatibility according to ISO 10993.
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.
WaveWire/WaveMap Pressure System. K965140
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
Jomed Inc. April 2002 SmartWire/SmartMa Special 510(k)
510K) Summary of Safety and Effectiveness
| Date Prepared: | April 12, 2002 |
|---|---|
| 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 Name: | Jometrics SmartWire/SmartMap Pressure System |
| Classification Name: | Catheter guide wire |
| Cardiovascular blood flow meter | |
| Catheter tip pressure transducer | |
| Vessel occlusion transducer | |
| Patient transducer and electrical cable (including connector) | |
| Predicate Device: | WaveWire/WaveMap Pressure System. K965140 |
Device Description:
The Jometrics SmartWire/SmartMap Pressure System consists of the SmartWire and the SmartMap. Additionally, the SmartWire can be used with the existing WaveMap with the inclusion of the Patient Cable Model 8000.
The SmartWire is a steerable pressure monitoring guide wire used to obtain intracoronary pressure measurements before, during, and after interventional procedures. There are two lengths. 189 cm and 300 cm and the outside diameter is .014". The screw tip, core wire, proximal coil and hypotube are manufactured from stainless steel. The tip coil is composed of a platinum, iridium alloy and coated to provide lubricity. The hypotube and proximal coil are also coated to provide lubricity.
The SmartMap is designed to interface a SmartWire Pressure Wire to the auxiliary input of hemodynamic (Physio Monitor) systems. The SmartMap's power is derived from the hemodynamic system and provides in return an industry standard (AAMI BP22-2-1994) 5uV/V/mmHg output back to the hemodynamic system.
The instrument is intended to measure pressure from a pressure sensor on a guide wire in the coronary and peripheral vasculature during diagnostic and/or interventional procedures.
1
Jomed Inc. April 2002
510(k) Summary (cont'd)
The Patient Cable Model 8000 is a preamplifier/signal condition unit designed to interface the SmartWire family of wires to an existing WaveMap Instrument. It uses intelligence to set up the circuitry designed to process the SmartWire as done in the SmartMap so that SmartWires may be used with either the SmartMap or the WaveMap.
Intended Use:
The SmartWire/SmartMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The SmartWire can also be used in replacement of an angioplasty guide wire to facilitate the placement of a balloon dilation catheter, as well as other interventional devices. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Device Technological Characteristics and Comparison to Predicate Device:
The SmartWire/SmartMap Pressure System uses the same fundamental scientific technology and intended use as that of the predicate device, the WaveWire/WaveMap Pressure System.
Performance Data:
Applicable testing was performed to evaluate the changes in the SmartWire/SmartMap Pressure System. The testing results were found to be comparable to those of the predicate device, the WaveWire/WaveMap Pressure System. All new materials were tested for biocompatibility according to ISO 10993.
Conclusion:
The SmartWire/SmartMap Pressure System utilizes the same fundamental scientific technology as that of the predicate device, the WaveWire/WaveMap Pressure System. The performance data and a declaration of conformity with design controls support a determination of substantial equivalence of the modified device, SmartWire/SmartMap Pressure System to the predicate device, WaveWire/WaveMap Pressure System.
KO21219
_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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2002
Mr. Terry Schultz Regulatory Affairs Manager Jomed, Inc. 2870 Kilgore Rd. Rancho Cordova, CA 95670
Re: K021219
SmartWire/SmartMap Pressure System Regulation Number: 870.1330, 870.2870 Regulation Name: Catheter guide wire, Catheter tip pressure transducer Regulatory Class: II (two) Product Code: 74 DQX, DXD Dated: April 16, 2002 Received: April 17, 2002
Dear Mr. 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 - Mr. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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,
N.G. Tiller
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Jomed Inc. April 2002 SmartWire/SmartMap Special 510(k)
510(k) Number (if known):
Device Name: SmartWire/SmartMap Pressure System
Indications for Use:
The SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, I he Sinal White Smarthup Fressure Byoss to measures blood pressure during diagnostic angiography and/or interventional procedures. :
The intended use and indications for use of the modified device as described in its labeling The included use and microations for ientific technology of the modified device has not changed.
(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 Use | |
|---|---|
| ---------------------- | -- |
Division of Carding: 510(k) Number