(91 days)
Not Found
No
The description focuses on hardware modifications (High Dynamic Range Console, reinforced wire tips) and existing technologies (Optical Coherence Reflectometry, Radio Frequency energy). There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is used to ablate tissue and create a passage for wire advancement, which directly treats an arterial occlusion.
No
The device is designed to facilitate the placement of other devices and ablate tissue to create a passage, which are therapeutic actions, not diagnostic. While it uses Optical Coherence Reflectometry for navigation and visualization, this is for guiding the therapeutic procedure rather than diagnosing a condition.
No
The device description clearly outlines hardware components including a High Dynamic Range Console, Crossing Wires, Safe Torquer, and tip shaping tool, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Safe-Cross® Radio Frequency Total Occlusion Crossing System is a medical device used within the body (in vivo) to facilitate the placement of other devices during percutaneous interventions. It uses radio frequency energy and optical coherence reflectometry to navigate and ablate tissue within arteries.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. Its function is to physically interact with and modify tissue within the patient's arteries.
Therefore, the Safe-Cross® Radio Frequency Total Occlusion Crossing System falls under the category of an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary and peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
Product codes
DQX
Device Description
The Safe-Cross® Radio Frequency Total Occlusion Crossing System provides Optical Coherence Reflectometry for navigation through vessels allowing visualization of the Safe-Cross Crossing Wire tip. Radio Frequency energy is provided to the wire's distal tip in order to ablate tissue to create a passage for wire advancement through difficult sections of arterial occlusions. The System was modified to add a High Dynamic Range Console to the product line, which allows more light to penetrate and reflect off tissue improving the overall range of the system; and to modify the Crossing Wires to reinforce the distal tip.
The Safe-Cross Crossing Wires are provided EtO sterile for single use in the following sizes:
- .014" x 275 cm, straight or angled tip packaged with Safe Torquer and tip shaping tool; Coronary . and Peripheral use.
- .035" x 275 cm, straight or angled tip packaged with Safe-Cross Torquer; Peripheral use only. .
Mentions image processing
Optical Coherence Reflectometry
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Reflectometry
Anatomical Site
native coronary and peripheral arteries
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)
The Safe-Cross System has undergone the following testing: Console optics module verification and software validation: Crossing Wire biocompatibility, tensile, friction, torque response/strength and package integrity. Testing provides reasonable assurance of safety and effectiveness for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
| Submitted by: | Kensey Nash Corporation
735 Pennsylvania Drive
Exton, PA 19341 |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared by: | Jennifer J. Bosley, Regulatory Affairs Manager |
| Contact Person: | Robin Fatzinger, VP Clinical & Regulatory Affairs
Ph: (484) 713-2100 Fax: (484) 713-2903 |
| Date Prepared: | November 7, 2007 |
| Device Trade Name:
Common/Usual Name:
Proposed Classification: | Safe-Cross® Radio Frequency Total Occlusion Crossing System
Wire, Guide, Catheter
Catheter Guide Wire
21CFR § 870.1330 Class II, DQX—74 Cardiovascular |
Device Description:
The Safe-Cross® Radio Frequency Total Occlusion Crossing System provides Optical Coherence Reflectometry for navigation through vessels allowing visualization of the Safe-Cross Crossing Wire tip. Radio Frequency energy is provided to the wire's distal tip in order to ablate tissue to create a passage for wire advancement through difficult sections of arterial occlusions. The System was modified to add a High Dynamic Range Console to the product line, which allows more light to penetrate and reflect off tissue improving the overall range of the system; and to modify the Crossing Wires to reinforce the distal tip.
The Safe-Cross Crossing Wires are provided EtO sterile for single use in the following sizes:
- .014" x 275 cm, straight or angled tip packaged with Safe Torquer and tip shaping tool; Coronary . and Peripheral use.
- .035" x 275 cm, straight or angled tip packaged with Safe-Cross Torquer; Peripheral use only. .
Intended Use:
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary and peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
Predicate Devices:
K050915 - Safe-Cross® Radio Frequency Total Occlusion Crossing System (Intraluminal Therapeutics) K050916 - Safe-Cross® Radio Frequency Total Occlusion Crossing System (Intraluminal Therapeutics)
Substantial Equivalence:
The modified Safe-Cross System is substantially equivalent to the legally marketed predicate Safe-Cross devices now manufactured by Kensey Nash Corporation. Devices have same basic design and same materials, processing, intended use and fundamental scientific technology.
Non-Clinical Testing:
The Safe-Cross System has undergone the following testing: Console optics module verification and software validation: Crossing Wire biocompatibility, tensile, friction, torque response/strength and package integrity. Testing provides reasonable assurance of safety and effectiveness for its intended use.
1-484-713-2100
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
FEB -8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kensey Nash Corporation c/o Ms. Robin Fatzinger Vice President, Clinical & Regulatory Affairs 735 Pennsylvania Drive Exton, PA 19341
Re: K073162
Safe-Cross® Radio Frequency Total Occlusion Crossing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DQX Dated: January 10, 2008 Received: January 11, 2008
Dear Ms. Fatzinger:
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.
2
Page 2 -- Ms. Robin Fatzinger
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 Biometrics' (OSB) 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,
Duma R. Wachner
ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use Statement
510(k) Number (if known): KO73l 2_
Safe-Cross® Radio Frequency Total Occlusion Crossing System Device Name:
Indications For Use:
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary and peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
X Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nuna R. W. chmer
(Division Sign-Off)
Dision of Cardiovascular Devices
510(K) Number_K673162
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