(189 days)
The SCIMED ChoICE Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wire family is not intended for use in the cerebral vasculature.
The ChoICE Super Support and Super Support II Guide Wire models are steerable guide wires available in a nominal diameter of 0.014" and two tip configurations, straight shapeable and pre-formed J-Tip. A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating. The available lengths for the Super Support and Super Support II Guide Wire will be: ChoICE -190 cm, ChoICE Plus-182 cm, and ChoICE Exchange-300 centimeters.
The provided document is a 510(k) premarket notification for a medical device, specifically PTCA Guide Wires. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study with detailed statistical analysis.
Therefore, the input does not contain the kind of information requested for many of your points, such as:
- A table of acceptance criteria and reported device performance (in a quantifiable, statistically analyzed sense).
- Sample sizes for test sets, data provenance, or number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies with effect sizes.
- Standalone algorithm performance.
- Training set information.
Instead, the document describes non-clinical (in vitro) testing for the guide wires and states that the results verified that the device met minimum requirements for its intended use. It does not provide specific numerical acceptance criteria or performance metrics.
Here's an analysis based on the information available in the document, and an explanation for what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Minimum Requirements) | Reported Device Performance |
|---|---|
| Tip Tensile strength | Met minimum requirements |
| Tip Torsion strength | Met minimum requirements |
| Combined Load | Met minimum requirements |
| Tip Flexibility | Met minimum requirements |
| J-Tip Curve Retention | Met minimum requirements |
| Torque Response | Met minimum requirements |
| Proximal Spring Coil Joint Shear Strength | Met minimum requirements |
Explanation: The document states, "Test results verified that the ChoICE Super Support and Super Support II Guide Wire models met all of the minimum requirements and are adequate for their intended use." However, the specific numerical values for these "minimum requirements" (acceptance criteria) and the actual numerical results of the tests are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "Testing and evaluation of the guide wires included" the listed tests, but does not detail the number of units tested.
- Data Provenance: The tests conducted were "Non-Clinical Test Summary" and "in vitro testing and evaluation." This implies laboratory/bench testing, not data from human subjects or clinical settings. Therefore, country of origin is not applicable in the usual sense (it's manufactured in Maple Grove, MN, USA, as per the submitter's address). The study is non-clinical/in-vitro.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical/in-vitro engineering performance test. "Ground truth" in the context of expert review for medical imaging or clinical outcomes is not relevant here. The "ground truth" (or standard) for these tests would be established by engineering specifications and test methodologies.
4. Adjudication method for the test set:
- Not applicable. As this was non-clinical/in-vitro testing, there's no "adjudication" in the sense of reconciling human expert opinions. The results would be objectively measured against predefined engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a PTCA guide wire, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used:
- Ground Truth: For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards for guide wires, which dictate the "minimum requirements" mentioned in the results. This is established through materials science, biomechanical engineering principles, and regulatory requirements for medical devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
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Section 6
510(k) Notification SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires
Image /page/0/Picture/2 description: The image shows the logo for SCIMED, which is a medical device company. The logo consists of the word "SCIMED" in bold, black letters, with a black circle to the left of the word. Below the word "SCIMED" is the text "Boston Scientific Corporation" in a smaller font.
SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, MN 55311-1566 612.494.1700 MAY 2 | 1997
Summary of Safety and Effectiveness
Submitter's Information
Name and Address SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311
Contact Person Connie J. Del Toro (612) 494-2656
Date November 12, 1996
Device Name Proprietary Name SCIMED ChoICE Super Support PTCA Guide Wire SCIMED ChoICE Plus Super Support PTCA Guide Wire SCIMED ChoICE Exchange Super Support PTCA Guide Wire SCIMED ChoICE Super Support II PTCA Guide Wire SCIMED ChoICE Plus Super Support II PTCA Guide Wire SCIMED ChoICE Exchange Super Support II PTCA Guide Wire
Common or Usual Name PTCA Guide Wire
Classification Name Catheter Guide Wire (per 21CFR 870.1330)
Continued on next page.
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Image /page/1/Picture/1 description: The image shows the logo for SCIMED, a Boston Scientific Corporation. The logo features the word "SCIMED" in bold, sans-serif font, with a black circle to the left of the word. Below the word "SCIMED" is the text "Boston Scientific Corporation" in a smaller, sans-serif font. There is a horizontal line below the text "Boston Scientific Corporation".
SCIMED Life Systems, Inc.
Section 6 Summary of Safety and Effectiveness, continued
Predicate Devices
The ChoICE Super Support and Super Support II Guide Wire models are substantially equivalent to the following SCIMED products.
| Product | 510(k) | Clearance Date |
|---|---|---|
| ChoICE | K943192 | November 22, 1994 |
| K950141 | March 3, 1995 | |
| K961015 | May 15, 1996 | |
| ChoICE Plus | K945129 | March 3, 1995 |
| K961015 | May 15, 1996 | |
| ChoICE Exchange | K950113 | March 31, 1995 |
| K961015 | May 15, 1996 | |
| ChoICE PT Vision | K962572 | Currently under review. |
Device Description
The ChoICE Super Support and Super Support II Guide Wire models are steerable guide wires available in a nominal diameter of 0.014" and two tip configurations, straight shapeable and pre-formed J-Tip.
A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating.
The available lengths for the Super Support and Super Support II Guide Wire will be:
- · ChoICE -190 cm,
- · ChoICE Plus-182 cm, and
- · ChoICE Exchange-300 centimeters.
Continued on next page.
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Image /page/2/Picture/1 description: The image shows the logo for SCIMED, a Boston Scientific Corporation. The logo is black and white and features a stylized graphic to the left of the word "SCIMED". Below the word "SCIMED" is the text "Boston Scientific Corporation" in a smaller font. There is a horizontal line below the text.
SCIMED Life Systems, Inc.
| Summary of Safety and Effectiveness, continued | Section 6 | |
|---|---|---|
| -- | ------------------------------------------------ | ----------- |
| Intended Use | The ChoICE Super Support and Super Support II Guide Wire models are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wire family is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only. |
|---|---|
| Summary of Technological Characteristics | The ChoICE Super Support and Super Support II Guide Wire models utilize the same materials and methods of construction as the currently marketed ChoICE Guide Wire family and the recently submitted ChoICE PT Vision Guide Wire family. The differences necessary to create the Super Support and Super Support II Guide Wire models are the slight variation of the distal core wire tapers and the reduced length of the polyurethane sleeve. |
| Non-Clinical Test Summary | Testing and evaluation of the guide wires included: |
| Tip Tensile,Tip Torsion,Combined Load,Tip Flexibility,J-Tip Curve Retention,Torque Response, andProximal Spring Coil Joint Shear Strength. | |
| ResultsTest results verified that the ChoICE Super Support and Super Support II Guide Wire models met all of the minimum requirements and are adequate for their intended use. |
Continued on next page.
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Image /page/3/Picture/1 description: The image shows the logo for SCIMED, a Boston Scientific Corporation. The logo features a large, solid black circle to the left of the word "SCIMED" in bold, sans-serif font. Below "SCIMED" is the text "Boston Scientific Corporation" in a smaller, less bold font. There is a registered trademark symbol to the right of the word "SCIMED".
SCIMED Life Systems, Inc.
Summary of Safety and Effectiveness, continued
Section 6
发
Non-Clinical Test Summary, continued
Summary
The Super Support and Super Support II models are considered to be substantially equivalent to the currently marketed ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires and the recently submitted ChoICE PT Vision Guide Wire family, based on a comparison of intended use, design and the results of in vitro testing and evaluation.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three horizontal bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 | 1997
Ms. Connie J. Del Toro - - - - -Regulatory Affairs Associate Scimed Life Systems, Inc. One Scimed Place Maple Grove, Minnesota 55311-1566
Re : K964551 SCIMED® ChoICE™ PTCA Guide Wires SCIMED® ChoICE™ Plus PTCA Guide Wires SCIMED® ChoICE™ Exchange PTCA Guide Wires Super Support and Super Support II Models Regulatory Class: II (two) Product Code: DQX Dated: March 3, 1997 Received: March 4, 1997
Dear Ms. Del Toro:
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 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
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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 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 regulations.
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) 594-4648. 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" (21 CFR 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 at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Section 2
| 510(k) Number | K964551 |
|---|---|
| Device Name | ChoICE PTCA Guide WiresChoICE Plus PTCA Guide WiresChoICE Exchange PTCA Guide Wires |
| Indicationsfor Use | The SCIMED ChoICE Guide Wires are intended to facilitate theplacement of balloon dilatation catheters or other therapeutic devicesduring PTCA or other intravascular interventional procedures. TheChoICE Guide Wire family is not intended for use in the cerebralvasculature. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF) ------------------
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over The Counter Use | _________________ |
|---|---|
| ---------------------- | ------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular,and Neurological Devices |
| 510(k) Number | R964551 |
|---|---|
| --------------- | --------- |
(Optional Format 1-2-96)
§ 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.