(97 days)
Quick-Cross® Extreme Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter 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.
The Spectranetics Quick-Cross Extreme Support Catheters are physical medical devices, not AI/ML (Artificial Intelligence/Machine Learning) software. Therefore, the questions related to AI/ML specific criteria such as acceptance criteria for AI models, sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, do not apply to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, design, construction, specifications, intended use, and performance, primarily through bench testing.
Here's an interpretation of the relevant information provided:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly list a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner as one might see for an AI/ML device. Instead, the acceptance criteria are inherent in demonstrating substantial equivalence to predicate devices. The "reported device performance" is a summary statement that these criteria were met through comparative testing.
| Acceptance Criterion (Implicit for Substantial Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Guide and support a guidewire during vasculature access | Achieved (stated in intended use) |
| Allow for wire exchanges | Achieved (stated in intended use) |
| Provide a conduit for delivery of saline solutions or diagnostic contrast agents | Achieved (stated in intended use) |
| Equivalent physical dimensions (e.g., OD, working length, guidewire compatibility) | Quick-Cross Extreme models have the same specifications as listed (e.g., Models 518-076 to 518-083, 4Fr, 0.059" OD, 65-150cm working length, .035" guidewire comp.). "Test results show that the Spectranetics Quick-Cross Extreme Support Catheters are equivalent to the predicate devices." |
| Equivalent infusion rates | "Test results show that the Spectranetics Quick-Cross Extreme Support Catheters are equivalent to the predicate devices." |
| Equivalent burst pressure | "Test results show that the Spectranetics Quick-Cross Extreme Support Catheters are equivalent to the predicate devices." |
| Biocompatibility in conformance with ISO 10993-1:2003 | Confirmed (utilizing identical component materials as predicate devices) |
| Device integrity and functionality qualified/validated | Qualified and/or validated using samples produced under routine manufacturing conditions. |
| Sterilization in conformance with ANSI/AAMI/ISO 11135:1994 | Protocol prepared and executed for Ethylene Oxide Sterilization. |
| Meet or exceed requirements in ISO 1055-1 (Sterile, Single-use Intravascular Catheters - Part 1: General Requirements) | All models meet or exceed these requirements. |
| Package integrity validated | Initially validated in conjunction with sterilization studies. |
| Technical characteristics (e.g., stainless steel braided shaft, tapered tip, diameter) equivalent to predicate devices | "Have the same technical characteristics as the Terumo 4Fr Radifocus Optitorque (GlideCath) and the Quick-Cross Support Catheters, the predicate devices." (e.g. 0.066 inch diameter with capacity for 0.035" guidewires) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "comparative laboratory testing" and "samples produced under routine manufacturing conditions" for device integrity and functionality. However, specific sample sizes (e.g., number of catheters tested for burst pressure) are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, but it's implied to be internal laboratory testing conducted by Spectranetics Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the submission pertains to a physical medical device. Ground truth, in the context of AI/ML, refers to annotated data. For this device, "ground truth" would more accurately be defined by established engineering and material science standards and physical measurements. No external experts are mentioned for establishing ground truth in this context; rather, internal engineering and quality control procedures would have been followed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device submission focused on bench testing and substantial equivalence.
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 is a physical support catheter, not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is fundamentally based on established engineering specifications, material properties, and performance benchmarks set by international standards (ISO and ANSI/AAMI) and comparative data against the predicate devices. This includes physical dimensions, material biocompatibility, mechanical strength (burst pressure), and flow characteristics (infusion rates).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device.
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510(k) Summary
SUBMITTER INFORMATION
DEC 1 0 2008
KORZS
page 1 of 2
- 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
- Vice President, Global Regulatory Affairs & Compliance
DEVICE IDENTIFICATION
- A. Device Trade Name: Spectranetics Quick-Cross Extreme Support Catheters
- B. Device Common Name: Support Catheters
- C. Classification Name: Catheter, Percutaneous
- D. Device Class: Class II (per 21 CFR 870.1330)
- E. Device Code: DQY
CLAIMED EQUIVALENCE
Quick-Cross® Support2 Catheters (K991059, K022138, K033678, and K072750)
4Fr Terumo RadiFocus Optitorque (K992051)
DEVICE DESCRIPTION
Specifications:
| Model(Ref.) | Size | Max. (OD)OuterDiameter | WorkingLength | Guide WireCompatability | *MaxPressurepsi (kPa) | Tip Shape |
|---|---|---|---|---|---|---|
| 518-076 | 4 Fr | 0.059" / 1.50 mm | 65 cm | .035" | 500 (3447) | Straight |
| 518-078 | 4 Fr | 0.059" / 1.50 mm | 90 cm | .035" | 500 (3447) | Straight |
| 518-080 | 4 Fr | 0.059" / 1.50 mm | 135 cm | .035" | 500 (3447) | Straight |
| 518-082 | 4 Fr | 0.059" / 1.50 mm | 150 cm | .035" | 500 (3447) | Straight |
| 518-077 | 4 Fr | 0.059" / 1.50 mm | 65 cm | .035" | 500 (3447) | Angled |
| 518-079 | 4 Fr | 0.059" / 1.50 mm | 90 cm | .035" | 500 (3447) | Angled |
| 518-081 | 4 Fr | 0.059" / 1.50 mm | 135 cm | .035" | 500 (3447) | Angled |
| 518-083 | 4 Fr | 0.059" / 1.50 mm | 150 cm | .035" | 500 (3447) | Angled |
- 75/25 Optiray 320 Contrast Sterile Saline
All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter 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.
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INTENDED USE
Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
IDENTIFICATION OF PREDICATE DEVICES
Spectranetics Quick-Cross Extreme Support Catheters are equivalent to the Terumo 4Fr Radifocus Optitorque Angiographic Catheter (K992051), marketed as the 5Fr Radifocus Glidecath, with regard to materials, basic design principles, construction, specifications, intended use and performance. It is also equivalent to the Spectranetics Quick-Cross Support Catheter 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 Extreme Support Catheters are equivalent to the predicate devices with regard to safety, effectiveness, indication and performance.
BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING
Quick-Cross Extreme Support Catheters are built from the same components and materials of construction as the predicate devices, already-marketed products. Biocompatibility of the finished Quick-Cross Extreme Support Catheters utilizing identical component materials have been 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 Extreme Support Catheters models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 1055-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements. Package integrity was initially validated in conjunction with sterilization studies.
TECHNILOGICAL CHARACTERISTICS
The Spectranetics Quick-Cross Extreme Support Catheters have the same technical characteristics as the Terumo 4Fr Radifocus Optitorque (GlideCath) and the Quick-Cross Support Catheters, the predicate devices. Both devices feature a stainless steel braided shaft for aided support and torque response and a tapered tip. All support catheters have a 0.066 inch diameter with the capacity to accommodate up to 0.035" diameter quidewires depending on the model.
CONCLUSION
The Spectranetics Quick-Cross Extreme Catheters are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2008
Spectranetics Corporation, Inc. c/o Mr. Michael K. Handley Vice President Global Regulatory Affairs & Compliance 9965 Federal Drive Colorado Springs, CO 80921
Re: K082561
Spectranetics Quick-Cross® Extreme Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 18, 2008 Received: November 19, 2008
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, 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
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Page 2 - Mr. Michael K. Handley
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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting 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,
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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.spectranetlcs.com
510(k) #: K082561
Statement of Indication for Use
Device Name: Spectranetics Quick-Cross® Extreme Support Catheters
Indications for Use
Quick-Cross® Extreme Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Prescription Use XXXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
(Division/Sign-Off)
Division of Cardiovascular, Devices
510(k) Number K082561
§ 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).