(91 days)
The Spectranetics Quick-Cross Support Catheters are a guidewire exchange and infusion device designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The Spectranetics Quick-Cross Support Catheters are intravascular catheters, available in seven (7) models:
518-032 0.014" diameter catheter, 135cm length
518-033 0.018" diameter catheter 90 cm length
518-034 0.018" diameter catheter 135 cm length
518-035 0.018" diameter catheter 150 cm length
518-036 0.035" diameter catheter 90 cm length
518-037 0.035" diameter catheter 135 cm length
518-038 0.035" diameter catheter 150 cm length
Model number 518-032 has a shaft of varying stiffness with a proximal shaft diameter of 3.0 Fr. tapering to a distal shaft diameter of 1.9 Fr.
Model numbers 518-033, 518-034, and 518-035 have a shaft of varying stiffness with a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.2 Fr.
Model numbers 518-036, 518-037, and 518-038 have a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. tapering to a distal shaft diameter of 3.7 Fr.
All models have three (3) radiopaque markers located at their tapered distal tip. A standard female luer is placed on the proximal end of each model. The distal 40 cm of each model is coated with a lubricious, hydrophilic coating.
The provided text describes a 510(k) premarket notification for the Spectranetics Quick-Cross Support Catheter. This document asserts substantial equivalence to predicate devices based on non-clinical testing rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Inferred from "design validation protocols and risk analysis addressed all known aspects of the device", but no specific thresholds are provided) | Reported Device Performance (Summary statement, no specific data) |
|---|---|
| Tensile strength | Demonstrated to be safe and effective |
| Functionality | Demonstrated to be safe and effective |
| Visibility | Demonstrated to be safe and effective |
| Flow rate | Demonstrated to be safe and effective |
| Sterility | Demonstrated to be safe and effective |
| Biocompatibility | Demonstrated to be safe and effective |
| (Implicit) Substantial equivalence to predicate devices | Bench testing results demonstrate substantial equivalence |
2. Sample sized used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: "Bench testing." The document does not specify country of origin or if the data was retrospective or prospective, as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a clinical study involving expert interpretation of data or images. The "ground truth" for non-clinical testing would be the physical properties and performance metrics of the device itself.
4. Adjudication method for the test set:
- Not applicable, as there's no interpretation by experts involved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This is a non-clinical 510(k) submission for a medical device (catheter), not an AI or imaging diagnostic device that would typically undergo MRMC studies.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- For non-clinical testing, the "ground truth" refers to the established standards or expected performance characteristics for physical properties (e.g., tensile strength, flow rate, biocompatibility testing results). The document does not specify these standards or the specific results. It only states that the testing provided "reasonable assurance that the device will perform in a safe and effective manner."
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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FEB 2 3 2004
Premarket Notification 510(k) Summary
Submitted By: Michael J. Ryan RA Manager Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907 Signature and Date:
7 Michael J. Ba 21 Nov 03
Device Trade Name: Common Name: Classification Name:
Device Description:
Intravascular Catheter Percutaneous Catheter, CFR 870.1250
Spectranetics Quick-Cross Support Catheter.
The Spectranetics Quick-Cross Support Catheters are intravascular catheters, available in seven (7) models:
| 518-032 | 0.014" diameter catheter, | 135cm length |
|---|---|---|
| 518-033 | 0.018" diameter catheter | 90 cm length |
| 518-034 | 0.018" diameter catheter | 135 cm length |
| 518-035 | 0.018" diameter catheter | 150 cm length |
| 518-036 | 0.035" diameter catheter | 90 cm length |
| 518-037 | 0.035" diameter catheter | 135 cm length |
| 518-038 | 0.035" diameter catheter | 150 cm length |
Model number 518-032 has a shaft of varying stiffness with a proximal shaft diameter of 3.0 Fr. tapering to a distal shaft diameter of 1.9 Fr.
Model numbers 518-033, 518-034, and 518-035 have a shaft of varying stiffness with a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.2 Fr.
Model numbers 518-036, 518-037, and 518-038 have a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. tapering to a distal shaft diameter of 3.7 Fr.
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| All models have three (3) radiopaque markers located at their tapered distal tip. A standard female luer is placed on the proximal end of each model. The distal 40 cm of each model is coated with a lubricious, hydrophilic coating. Predicate devices of this type with similar intended uses have been classified into Class II. | |
|---|---|
| Indications for Use: | The Spectranetics Quick-Cross Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. |
| Substantial Equivalence: | This product is substantially equivalent in design, composition, function, and intended use to the Spectranetics Support Catheters, 510(k) K991059 and K022138. |
| Technological Characteristics & Nonclinical Testing Summary: | The Spectranetics Quick-Cross Support Catheters are similar in design, construction, indications, target population, risk analysis, performance and materials to the predicate devices, the Spectranetics 0.014" and 0.018" Support Catheters, K991059, and the Spectranetics 0.035" Support Catheter, K022138. Spectranetics New Production Introduction procedure has been used in concert with the Quality System Regulations for the introduction of the Quick Cross Support Catheter. The design validation protocols and risk analysis addressed all known aspects of the device including tensile strength, functionality, visibility, flow rate, sterility, and biocompatibility. Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the device will perform in a safe and effective manner when used as indicated The Spectranetics Quick-Cross Support Catheters are similar in the indications for use as the Spectranetics Support Catheters K991059 and K022138. |
| Conclusions: | The results of the bench testing demonstrate that the Spectranetics Quick-Cross Support Catheters are substantially equivalent to the predicate devices and they will perform in a safe and effective manner when used as indicated. |
:
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2004
Spectranetics Corporation c/o Mr. Michael J. Ryan Regulatory Affairs Manager 96 Talamine Court Colorado Springs, CO 80907
Re: K033678
Spectranetics Quick-Cross Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: November 21, 2003 Received: November 25, 2003
Dear Mr. Ryan:
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 (sec 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
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Page 2 - Mr. Michael J. Ryan
or any Federal statutes and regulations administered by other Federal agencies. You must of any Federal statutes and regulations and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regulations 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (overies (overies as described in your Section 510(k) This letter whil anow you to begin manteg of substantial equivalence of your device to a legally premarket nothleation: "The PDA miding of basification 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 If you desire specific advice ion 100 (301) 594-4648. 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 other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(501) 445 0577 01 at 10 no 10 m / ds mamain . html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:___Spectranetics Quick-Cross Support Catheter
Indications For Use:
The Spectranetics Quick-Cross Support Catheters are a guidewire exchange and infusion device designed for use in the vascular system. The catheters are intended to influsion action acolgins for access of the vasculature, allow for exchange of guidewires, support a galownio dainly dooses on of saline solutions or diagnostic contrast agents.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hatal Sign Off
510(k) Numb
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).