(52 days)
No
The description focuses on the physical characteristics and intended use of a balloon catheter, with no mention of AI/ML or software processing of data.
Yes
The device is intended to dilate stenoses in various arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae, directly treating medical conditions.
No
The device is a Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter intended to dilate stenoses and for post-dilatation of stents, which are therapeutic actions, not diagnostic ones. While it uses radiopaque markers for placement under fluoroscopy, fluoroscopy is used for guidance during a therapeutic procedure, not for diagnosis by the device itself.
No
The device description clearly details a physical catheter with a balloon, guide wire compatibility, and radiopaque markers, indicating it is a hardware device used in a physical procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to perform a physical procedure (dilating arteries and fistulae). IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details a catheter with an inflatable balloon designed for insertion into blood vessels. This is consistent with an interventional medical device, not a diagnostic test performed on a sample.
- Mechanism of Action: The device works by physically expanding a balloon to open narrowed vessels. IVDs work by analyzing biological or chemical properties of a sample.
- Input: The input is the patient's anatomy and the guide wire/introducer, not a biological specimen.
- Anatomical Site: The device is used directly within the patient's circulatory system.
Therefore, the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, poplited, infra poplited and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and selfexpanding stents in the peripheral vasculature.
Product codes
LIT
Device Description
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which is the same device as its predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333), with an additional indication. The device has identical technological characteristics as the predicate, SABER™ .035 PTA Dilatation Catheter (K201333). SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI).
The SABER™ .035" PTA Dilatation Catheter has identical device/component constructions as the predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). Same as the predicate, the balloon of the SABER™ .035 PTA Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement when under fluoroscopy. The SABER™ .035 PTA Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a quide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon.
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries, peripheral vasculature
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
Design Verification and Validation (DV&V) testing was performed to verify that the proposed SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter meets the pre-determined safety and performance requirements. Testing was also conducted to verify the effectiveness of the implemented risk control measures to mitigate the risks identified within the risk management process per ISO 14971: Medical Devices-Application of Risk Management to Medical Devices. The following design verification or performance testing of SABER™ .035 PTA Dilatation Catheter have been completed with favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards pertaining to evaluations of PTA Catheters.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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April 23, 2021
Cordis Corporation Wai Morgan Regulatory Affairs Principal Specialist 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
Re: K210626
Trade/Device Name: SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: February 26, 2021 Received: March 2, 2021
Dear Wai Morgan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210626
Device Name
SABERTM .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
Indications for Use (Describe)
SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, poplited, infra poplited and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and selfexpanding stents in the peripheral vasculature.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
l. Applicant/Manufacturer Information
Company: Cordis Corporation
Type of 510(k) Submission: Traditional 510(k) Premarket Notification 510(k) Correspondent: Ms. Wai Morgan(wai.morgan@cardinalhealth.com) Submission date: February 26, 2021
II. Requlatorv Information
Proposed Device:
- Trade/Proprietary Name: SABER™ .035 Percutaneous Transluminal ● Angioplasty (PTA) Dilatation Catheter
- Regulation Name: Percutaneous Catheter ●
- Classification Panel: Cardiovascular o
- Device Class: II o
- o Regulation Number: 21 CFR 870.1250
- Product Code: LIT ●
- . 510k Submitter: Cordis Corporation, (a Cardinal Health Company) 14201 N.W. 60th AVE. Miami Lakes, FL 33014 Tel: 305-528-6181 Establishment registration number: 1016427
- . Indications for Use: The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.
Predicate Device:
- Trade/Proprietary Name: SABER™.035 Percutaneous Transluminal 0 Angioplasty (PTA) Dilatation Catheter
- Regulation Name: Percutaneous Catheter ●
- Product Code: LIT
- 510k number: K201333
- 510k Submitter: Cordis Corporation, (a Cardinal Health Company) o 14201 N.W. 60th AVE. Miami Lakes, FL33014
- o Indications for Use: SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and
4
for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
III. Device Description of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter:
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon, which is the same device as its predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333), with an additional indication. The device has identical technological characteristics as the predicate, SABER™ .035 PTA Dilatation Catheter (K201333). SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate crossing of tight stenoses. SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is compatible with standard .035" guide wires and 5Fr, 6Fr and 7Fr catheter sheath introducers (CSI).
The SABER™ .035" PTA Dilatation Catheter has identical device/component constructions as the predicate, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). Same as the predicate, the balloon of the SABER™ .035 PTA Dilatation Catheter has radiopaque markers at the distal and proximal ends of the balloon working length to aid in balloon placement when under fluoroscopy. The SABER™ .035 PTA Dilatation Catheter has a proximal hub assembly that contains a luer locking connector with a balloon inflation port and a quide wire port. The balloon is inflated by injecting diluted contrast medium through the inflation port of the hub and the inflation lumen connected to the balloon.
The SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is intended for single use only and is provided sterile.
IV. Substantial Equivalence Assessments of Technological Characteristics:
Fundamental technological characteristics and raw material construction of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are identical to the predicate device, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333). . The operation principle, clinical applications, and instructions for use of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are similar to the predicate device. Both the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter and the predicate device (K201333) are indicated for use to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. In addition, the subject SABER™.035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is also indicated for post-dilatation of balloon-expandable and self-expanding stents in
5
the peripheral vasculature. Both the proposed and predicate devices are provided sterile with ethylene oxide sterilization and intended for single use only.
The proposed and predicate devices share the identical patient contacting materials, and the biocompatibility testing of the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter which was performed to verify conformance to the same requirements of the ISO 10993-1 (2018) standard for biological safety evaluation. Given all the critical technological characteristics as well as indications for use/intended use are similar, the proposed SABER™ .035 PTA Dilatation Catheter is assessed as substantially equivalent to the predicate device, SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter (K201333).
V. Biocompatibility Assessment
In accordance with ISO 10993-1: 2018, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the SABER™ .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is classified as "Externally Communicating Devices, Circulating
blood, Limited Contact (