(68 days)
The Spectranetics Quick-Cross Support2 Catheter is designed for use in the vascular system. The catheters are intended to support a guide wire during access to the vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Model number 518-065 has a shaft of varying stiffness with a proximal shaft diameter of 3 Fr. Tapering to a distal shaft diameter of 1.9 Fr and is compatible with a 0.014 inch or smaller guide wire.
Model number 518-066 has a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. Tapering to a distal shaft diameter of 3.7 Fr and is compatible with a 0.035 inch or smaller guide wire.
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. The support catheters are single-use and provided in sterile packaging.
Spectranetics Quick-Cross Support2 Catheters have the same technical characteristics as the predicate devices, the unmodified Quick-Cross Support2 Catheters. Both are constructed from HDPE extruded tubing, HDPE molded luers, and platinum/iridium bands. All support catheters have a 0.068 inch maximum diameter with the capacity to accommodate 0.014" - 0.035" diameter guide wires depending on the model (see table below).
| Model number | Wire compatibility | Sheath Compatibility | Length |
|---|---|---|---|
| 518-065 | 0.014" diameter | 5Fr | 150 cm |
| 518-066 | 0.035" diameter | 5Fr | 65 cm |
The provided text describes the Spectranetics Quick-Cross Support2 Catheter and its substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria for AI/ML performance.
Therefore, I cannot extract information related to:
- A table of acceptance criteria and the reported device performance: This document does not specify performance metrics in the way an AI/ML study would (e.g., accuracy, sensitivity, specificity). Instead, it refers to "comparative laboratory testing" for physical dimensions, infusion rates, and burst pressure, stating that the device is "equivalent" in safety, effectiveness, indication, and performance to predicate devices.
- Sample sized used for the test set and the data provenance: There is no mention of a "test set" in the context of an AI/ML model or data provenance. The testing conducted was for physical characteristics, not algorithm performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no discussion of expert ground truth establishment for an AI/ML model.
- Adjudication method: Not applicable to this type of device submission.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as there is no algorithm described.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as there is no mention of an AI/ML training set.
- How the ground truth for the training set was established: Not applicable.
The document is a 510(k) summary for a medical device (a support catheter), which focuses on demonstrating "substantial equivalence" to already-marketed predicate devices through comparative testing of physical and material properties, rather than validating an AI/ML algorithm.
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Ko72750 pg 1 of 3
510(k) Summary
SUBMITTER INFORMATION
DEC 0 4 2007
- A. Company Name: Spectranetics Corporation, Inc.
- B. Company Address: 96 Talamine Court Colorado Springs, Colorado 80907
- C. Company Phone: 719-633-8333 / 1-800-633-0960
- D. Company Facsimile: 719-447-2040
- E. Contact Person: Michael K. Handley Director, Global Regulatory Affairs
DEVICE IDENTIFICATION
- A. Device Trade Name: Spectranetics Quick-Cross Support2 Catheter
- B. Device Common Name: Support Catheter
- C. Classification Name: Catheter, Percutaneous
- D. Device Class: Class II (per 21 CFR 870.1330)
- E. Device Code: DQY
CLAIMED EQUIVALENCE
Spectranetics Quick-Cross Support2 Catheter Models: 0.014" (K991059), 0.035" (K022138), and modified 0.014"/0.035" (K033678)
DEVICE DESCRIPTION
| Model number | Wire compatibility | Sheath Compatibility | Length |
|---|---|---|---|
| 518-065 | 0.014" diameter | 5Fr | 150 cm |
| 518-066 | 0.035" diameter | 5Fr | 65 cm |
Model number 518-065 has a shaft of varying stiffness with a proximal shaft diameter of 3 Fr. Tapering to a distal shaft diameter of 1.9 Fr and is compatible with a 0.014 inch or smaller guide wire.
Model number 518-066 has a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. Tapering to a distal shaft diameter of 3.7 Fr and is compatible with a 0.035 inch or smaller guide wire.
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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. The support catheters are single-use and provided in sterile packaging.
INTENDED USE
The Spectranetics Quick-Cross Support2 Catheter is designed for use in the vascular The catheters are intended to support a guide wire during access to the system. vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
IDENTIFICATION OF PREDICATE DEVICES
Spectranetics Quick-Cross Support Catheters are equivalent to the Spectranetics Quick-Cross Support Catheters (K033678, K022138, and K991059) with regard to materials, basic design principles, construction, specifications, intended use and performance. Both are examples of a support catheter for guide wires, a common and familiar tool of cardiovascular interventionist.
COMPARISON TO PREDICATE DEVICES
Comparative laboratory testing was conducted to assess physical dimensions, infusion rates and burst pressure. Test results show that the Spectranetics Quick-Cross Support' Catheters are equivalent to the predicate devices (unmodified Quick-Cross Support Catheters) with regard to safety, effectiveness, indication and performance.
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
Quick-Cross Support2 Catheters are built from the same components and materials of construction as the unmodified Quick-Cross Support" Catheters, already-marketed products. Therefore, biocompatibility of the finished Quick-Cross Support2 Catheters utilizing identical component materials have been previously confirmed in conformance with ISO 10993-1:2003, Biological Evaluation of Medical Devices. Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. An internal company protocol was prepared and executed in conformance with ANSI/AAMI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. All Quick-Cross Support2 Catheters models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 10555-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements. Package integrity was initially validated in conjunction with sterilization studies.
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K072750 pg 3 of 3
TECHNICOLOGICAL CHARACTERISTICS
Spectranetics Quick-Cross Support2 Catheters have the same technical The characteristics as the predicate devices, the unmodified Quick-Cross Support2 Catheters. Both are constructed from HDPE extruded tubing, HDPE molded luers, and platinum/iridium bands. All support catheters have a 0.068 inch maximum diameter with the capacity to accommodate 0.014" - 0.035" diameter guide wires depending on the model (see table below).
| Model number | Wire compatibility | Sheath Compatibility | Length |
|---|---|---|---|
| 518-065 | 0.014" diameter | 5Fr | 150 cm |
| 518-066 | 0.035" diameter | 5Fr | 65 cm |
CONCLUSION
The Spectranetics Quick-Cross Support2 Catheters are substantially equivalent to the unmodified Quick-Cross Support2 Catheters.
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2007
The Spectranetics Corporation c/o Mr. Michael K. Handley Director Global Regulatory Affairs 96 Talamine, CT. Colorado Springs, CO 80907
Re: K072750
Trade/Device Name: Quick Cross Support 2 Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Support Catheter Regulatory Class: II (two) Product Code: DQY Dated: November 8, 2007 Received: November 14, 2007
Dear Mr. Handley:
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 your device in the Federal Register.
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Page 2 - Mr. Michael K. Handley
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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Vohmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Statement of Indication for Use
Device Name: Quick-Cross® Support2 Catheter
Indications for Use
The Spectranetics Quick-Cross Support2 Catheters are designed for use in the vascular system. The catheters are intended to support a guide wire during access to the vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Prescription Use XXXX (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)
Duana P. Arslanian
(Division Sign-Off) Oivision of Cardiovascular Devices
510(k) Number_K072750
§ 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).