(365 days)
Not Found
No
The description focuses on the physical components and their function in measuring and transmitting pressure signals. There is no mention of AI, ML, or any computational analysis of the data beyond display on a standard physiological monitor.
No.
The device is intended to monitor blood pressure and facilitate the placement of other therapeutic devices, not to provide therapy itself.
Yes
The device is intended to "monitor the mean intravascular blood pressure", which is a diagnostic function used to assess a patient's physiological state.
No
The device description explicitly lists hardware components: a guide wire, a disposable transducer with attached cable, and a permanent cable.
Based on the provided information, the SCIMED Informer™ Pressure Wire System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used to monitor intravascular blood pressure and facilitate the placement of other devices during interventional procedures. This is a direct interaction with the patient's body in a clinical setting.
- Device Description: The components described (guide wire, transducer, cables) are designed for insertion into the vasculature and real-time measurement of pressure within the body.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) outside of the body. The pressure measurement is happening inside the blood vessels.
- In-Vivo Testing: The summary of performance studies explicitly mentions "In-Vivo testing was conducted to compare pressure reading capabilities and guide wire performance characteristics to currently marketed devices." This confirms the device's use within a living organism.
IVDs are devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. The SCIMED Informer™ Pressure Wire System does not fit this definition.
N/A
Intended Use / Indications for Use
The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts.
Product codes (comma separated list FDA assigned to the subject device)
74 DQX, 74 DRS, 74 DRA
Device Description
The SCIMED® Informer™ Pressure Wire System consists of the following components:
- · a guide wire,
- · a disposable transducer with attached cable, and
- · a permanent cable.
The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters.
The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravascular, not intended for use in the cerebral vasculature
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)
Non-Clinical Test Summary: In-Vitro testing and evaluations were performed on the Informer™ Guide Wire, the Informer™ Disposable Transducer with Attached Cable, the Informer™ Permanent Cable and the complete Informer™ System. Standard guide wire tests were used to evaluate the Informer™ Guide Wire. The Informer™ Disposable Transducer experienced standard ANSI/AAMI BP-22 testing while the cable testing included Cable Connection Cycling, Disposable Transducer Cable Connector Tensile, Transducer Housing/Cable Tensile, Strain Relief and Permanent Cable Connector Tensile. System Response and Shelf Life testing was conducted on complete Informer™ System units. Additionally, In-Vivo testing was conducted to compare pressure reading capabilities and guide wire performance characteristics to currently marketed devices.
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.
K943192, K945129, K950141, K950113, K961015, K965063, K964551, K942333, K946240, K950534, K960563, K910764, K942377, K925638, 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
NOV 1 2 1998
Summary of Safety and Effectiveness
| General
Information | Submitter's Name and Address | SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, MN 55311 |
|------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person | Jill Munsinger
(612) 494-2359 |
| | Classification Name(s) | Catheter Guide Wire, 21 CFR Part
870.1330; Transducer, Blood
Pressure, Extra Vascular, 21 CFR
Part 870.2850; Patient Transducer
and Electrode Cable, 21 CFR Part
870.2900 |
| | Common or Usual Name(s) | PTCA Guide Wire
Disposable Pressure Transducer
Cable, Patient Transducer |
| | Proprietary Name(s) | SCIMED® Informer™ Pressure
Wire System |
| | Product Code(s) | 74 DQX (Catheter Guide Wire)
74 DRS (Transducer, Blood
Pressure, Extra Vascular)
74 DRA (Patient Transducer and
Electrode Cable |
Predicate Devices
The SCIMED® Informer™ Pressure Wire is substantially equivalent to the products listed on the following page.
1
.
| Summary of Safety and Effectiveness, continued | |
|---|---|
| Intended Use | The SCIMED INFORMER™ Pressure Wire System is intended to |
| monitor the mean intravascular blood pressure and to facilitate the | |
| placement of balloon dilatation catheters or other therapeutic devices | |
| during PTCA or other intravascular interventional procedures. The | |
| phasic wave signal of the INFORMER Pressure Wire System is | |
| intended to facilitate placement of the wire. The INFORMER Pressure | |
| Wire System is not intended for use in the cerebral vasculature. | |
| The SCIMED INFORMER Pressure Wire System is not intended to be | |
| used in combination with any H.F. surgical equipment. | |
| The SCIMED INFORMER Pressure Wire System is indicated for use | |
| with all physiological monitors that meet IEC 601-1, IEC 601-2-34 | |
| standards. These monitors are required to meet electrical isolation for | |
| Type CF applied parts. | |
| Summary of | |
| Technological | |
| Characteristics | The Informer™ System is substantially equivalent to the currently |
| marketed SCIMED ChoICE™ and Sceptor PTCA Families of Guide | |
| Wires, the Namic Perceptor™ DT Disposable Transducer, the MEDEX | |
| TranStar Pressure Transducer, the BAXTER Edwards Permanent Cable | |
| Model PX-1800 and the Cardiometrics WaveWire/WaveMap Pressure | |
| System. | |
| Non-Clinical | |
| Test Summary | In-Vitro testing and evaluations were performed on the Informer™ Guide |
| Wire, the Informer™ Disposable Transducer with Attached Cable, the | |
| Informer™ Permanent Cable and the complete Informer™ System. | |
| Standard guide wire tests were used to evaluate the Informer™ Guide | |
| Wire. The Informer™ Disposable Transducer experienced standard | |
| ANSI/AAMI BP-22 testing while the cable testing included Cable | |
| Connection Cycling, Disposable Transducer Cable Connector Tensile, | |
| Transducer Housing/Cable Tensile, Strain Relief and Permanent Cable | |
| Connector Tensile. System Response and Shelf Life testing was | |
| conducted on complete Informer™ System units. | |
| Additionally, In-Vivo testing was conducted to compare pressure | |
| reading capabilities and guide wire performance characteristics to | |
| currently marketed devices. |
Summary of Safety and Effectiveness, continued
2
| Product | 510(k) | Clearance Date |
|---|---|---|
| ChoICE Guide Wire | K943192 | November 22, 1994 |
| ChoICE Guide Wire | K945129 | March 3, 1995 |
| ChoICE Guide Wire | K950141 | March 3, 1995 |
| ChoICE Guide Wire | K950113 | March 31, 1995 |
| ChoICE Guide Wire | K961015 | May 15, 1996 |
| ChoICE Guide Wire | K965063 | March 4, 1997 |
| ChoICE Guide Wire | K964551 | May 21, 1997 |
| Sceptor Guide Wire | K942333 | August 31, 1994 |
| Sceptor Guide Wire | K946240 | March 31, 1995 |
| Sceptor Guide Wire | K950534 | April 28, 1995 |
| Sceptor Guide Wire | K960563 | April 29, 1996 |
| Namic Perceptor DT | ||
| Disposable Transducer | K910764 | April 22, 1991 |
| Medex TranStar | ||
| Pressure Transducer | K942377 | August 16, 1994 |
| Baxter Edwards | ||
| Reusable PX-1800 | K925638 | October 18, 1993 |
| Cardiometrics | ||
| WaveWire/WaveMap | ||
| Pressure System | K965140 | August 18, 1997 |
Summary of Safety and Effectiveness, continued
Device Description
Predicate Devices, continued
The SCIMED® Informer™ Pressure Wire System consists of the following components:
- · a guide wire,
- · a disposable transducer with attached cable, and
- · a permanent cable.
The guide wire is a steerable coronary guide wire available in a nominal diameter of 0.014 inches, overall lengths of 185 and 300 centimeters, radiopaque tip lengths of 3 and 5 centimeters, straight and J-tip configurations and one tip flexibility that falls between the ChoICE Floppy and Intermediate models, similar to the ChoICE Extra Support. The guide wire is designed to monitor intravascular pressures and to facilitate the placement of balloon dilatation catheters.
The disposable transducer with attached cable converts hemodynamic pressure signals from the guide wire into electrical signals. This transducer interfaces with standard physiologic monitors to display the electrical signals in phasic waveforms via the permanent cable.
3
Image /page/3/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 a stylized image of an eagle with its wings spread, depicted in a minimalist, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 1998
Ms. Jill Munsinger Regulatory Affairs Associate SCIMED Life Systems, Inc. One Scimed Place Maple Grove, MN 55311-1566
Re: K974241 SCIMED® Informer™ Pressure Wire System Trade Name: Requlatory Class: II Product Code: DQX Dated: August 13, 1998 Received: August 14, 1998
Dear Ms. Munsinger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
4
Page 2 - Ms. Jill Munsinger
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahar , Ph.D Director Division of Cardiovascular, Respiratory And Neurolgoical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510(k) Number | K974241 |
|---|---|
| Device Name | SCIMED® Informer™ Pressure Wire System |
| Indications for Use | The SCIMED Informer™ Pressure Wire System is intended to monitor the mean intravascular blood pressure and to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The phasic wave signal of the INFORMER Pressure Wire System is intended to facilitate placement of the wire. The INFORMER Pressure Wire is not intended for use in the cerebral vasculature. The SCIMED INFORMER Pressure Wire System is not intended to be used in combination with any H.F. surgical equipment. The SCIMED INFORMER Pressure Wire System is indicated for use with all physiological monitors that meet IEC 601-1, IEC 601-2-34 standards. These monitors are required to meet electrical isolation for Type CF applied parts. |
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and IVC.
510(k) Number K974241
(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) OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________