(88 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML technology.
No
The device is indicated for enabling diagnosis by facilitating diagnostic devices, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" section states that the catheters are indicated for "enabling diagnosis of various pathologies."
No
The device description clearly describes a physical catheter with specific material and construction details, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature." This describes a device used in vivo (within the body) to assist in diagnostic procedures, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a catheter designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Cordis INFINITI Ambi Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation.
The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations.
The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to ensure the safety and effectiveness of the device with the minor design changes demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed.
Biocompatibility Testing:
The INFINITI Ambi Catheter is an externally communicating device with limited contact duration (≤ 24 hours) in contact with circulating blood. Biocompatibility testing, Chemical Characterization, and Toxicological Risk Assessment on the patient contacting portions of predicate device INFINITI 5F were performed. Testing was performed to meet the endpoints for evaluation from ISO 10993-1:2018 and FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on September 4, 2020. Endpoints evaluated are as follows:
- Physical and/or Chemical Information.
- Cytotoxicity - MEM Elution
- Sensitization – Guinea Pig Maximization
- Intracutaneous Irritation Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemocompatibility
Sterilization:
The sterilization conditions have been validated according to ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices to provide a sterility assurance level (SAL) of 10^-6.
Ethylene oxide and ethylene chlorohydrin residuals meet requirements for limited exposure devices (contact
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
November 21, 2023
Cordis US Corp. Zheng Wang Principal Specialist, Regulatory Affairs 14201 North West 60th Avenue Miami Lakes, Florida 33014
Re: K232573
Trade/Device Name: INFINITI™ Ambi Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: August 24, 2023 Received: August 25, 2023
Dear Zheng Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lydia S.
Glaw -S
Digitally signed by Lydia S. Glaw -S Date: 2023.11.21 13:17:34 -05'00'
Lydia Glaw 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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232573
Device Name INFINITI™ Ambi Angiographic Catheter
Indications for Use (Describe)
Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and 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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K232573 INFINITI™ Ambi Angiographic Catheter
510(k) Summary
I. SUBMITTER INFORMATION (807.92(a)(1))
| Manufacturer (Applicant): | Cordis US Corp.
14201 North West 60th Avenue
Miami Lakes, Florida, 33014 USA
Establishment Registration: 1016427 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s) | Zheng Wang (Jessie)
Principal Regulatory Affairs Specialist
Cordis US Corp.
5452 Betsy Ross Drive
Santa Clara, CA 95054, USA.
E-mail: zheng.wang04@cordis.com
Ana Lopez
Sr. Manager, Regulatory Affairs
Cordis US Corp.
5452 Betsy Ross Drive
Santa Clara, CA 95054, USA.
E-mail: ana.lopez02@cordis.com |
Date Prepared:
October 24, 2023
II. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | INFINITIT™ Ambi Angiographic Catheter
(hereafter referred as INFINITI Ambi Catheter) |
|----------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Diagnostic Intravascular Catheter |
| Classification: | Class II CFR Part 780.1200 |
| Classification Panel | Cardiovascular |
| Product Code: | DQO |
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Image /page/5/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The word is written in cursive, with the "C" being the largest letter and the other letters gradually decreasing in size. There is a registered trademark symbol to the right of the "s".
III. PREDICATE DEVICE
INFINITI™ Angiographic Catheter cleared on 9/30/1997 under K970854.
IV. DEVICE DESCRIPTION
The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation.
The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations.
The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas.
V. INTENDED/INDICATIONS FOR USE
Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating the positioning of diagnostic devices within the coronary and peripheral vasculature.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A comparison of the intended use/indications for use and technological characteristics are summarized in the table below. The minor design changes do not negatively impact the safety and effectiveness of the device.
| Element | Proposed Device
(INFINITI Ambi Catheter) | Predicate Device (K970854)
(INFINITI Catheter) | Note |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| FDA Product Code | DQO | DQO | Same |
| Indications for Use | Cordis catheters are indicated for
enabling diagnosis of various pathologies
by facilitating the positioning of
diagnostic devices within the coronary
and peripheral vasculature. | Cordis catheters are designed to deliver
radiopaque contrast medium to selected
sites in the vascular system. | Different |
| Intended Purpose | Cordis catheters are intended to delivery
radiopaque contrast medium to selected
sites in the vascular system. | Not included | Added |
| Contra-indications | None known | None known | Same |
| Manufacturer | Cordis US Corp. | Cordis Corporation | Different |
| Manufacturing Site | Cardinal Health México
244 S de RL de CV
Santiago Troncoso #808
Parque Industrial Salvarcar
Ciudad Juarez, Chihuahua | Cordis Corporation
14201 North West 60th Avenue Miami
Lakes, Florida 33014
USA | Different |
| Element | Proposed Device
(INFINITI Ambi Catheter) | Predicate Device (K970854)
(INFINITI Catheter) | Note |
| Sterilization Site | C.P. 32574
México
STERIS-E2
Isomedix Operations, Inc
1441 Don Haskins Drive
El Paso, TX 79936
USA
STERIS-E1
Isomedix Operations, Inc
1435 Isomedix Place
El Paso, TX 79936
USA
Sterigenics US, LLC
2400 Airport Road
Santa Teresa, NM 88008
USA | Cordis Europa N.V.
Postbus 38
Oosteinde 8
9300 AA Roden
The Netherlands
These two sites are no longer used for
the manufacturing of the Cordis
products.
For product manufactured in Miami:
Isomedix, Inc.
2072 Southport Road
Spartanburg, S.C. 29301-9539
Isomedix. Inc.
435 Whitney Street
Northborough, MA 01532
For product manufactured in Roden:
Griffith Micro Science
Storkstraat 8-10
2722 NN Zoetermeer
The Netherlands
These three sites are no longer used for
the sterilization of the Cordis products. | Different |
| Shelf Life | 3 years | 3 years | Same |
| Sterilization
Method | 100% Ethylene Oxide (EO) | 100% Ethylene Oxide (EO) | Same |
| Sterility Assurance
level (SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Use | Single Use | Single Use | Same |
| | Principle of Operation | | |
| Mechanism of
Action | Facilitates the delivery of radiopaque
contrast medium to selected sites in the
vascular system. | Facilitates the delivery of radiopaque
contrast medium to selected sites in the
vascular system. | Same |
| Overall length | 100cm, 125 cm | 100cm, 125 cm | Same |
| Element | Proposed Device
(INFINITI Ambi Catheter) | Predicate Device (K970854)
(INFINITI Catheter) | Note |
| Proximal OD | 5F – 0.066”
6F – 0.078” | 5F – 0.066”
6F – 0.078” | Same |
| Distal Tip OD | 5F – 0.066”
6F – 0.078” | 5F – 0.066”
6F – 0.078” | Same |
| Proximal ID | 5F – 0.047”
6F – 0.057” | 5F – 0.047”
6F – 0.057” | Same |
| Distal ID | 5F – 0.047”, Flush: 0.042”
6F – 0.057”, Flush: 0.042” | 5F – 0.047”, Flush: 0.042”
6F – 0.057”, Flush: 0.042” | Same |
| Guidewire
acceptance | 0.038” max | 0.038” max | Same |
| Maximum pressure | 1200 psi | 1200 psi | Same |
| Flow rate | 5F
21.3
6F
35 | 5F
21.3
6F
35 | Same |
| Catheter Component Materials | | | |
| Materials | Nylon and stainless-steel | Nylon and stainless-steel | Same |
| Product Design Characteristics | | | |
| Tip Length | 1.25 inches | 1.25 inches | Same |
| Shapes | JK 4.0, TG 4.5, JK 3.5, TG 4.0 | JR/JL | New |
| Packaging Configuration | | | |
| Sterile Packaging | Individual package, pouch, and carton | Individual package, pouch, and carton | Same |
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Image /page/6/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The font is a flowing script, with the letters connected to each other. The word is slightly slanted to the right, giving it a sense of movement. There is a trademark symbol to the right of the word.
K232573 INFINITI™ Ambi Angiographic Catheter
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Image /page/7/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The word is written in cursive, with the letters connected to each other. There is a registered trademark symbol to the right of the word. The font is bold and the color is a vibrant blue.
VII. PERFORMANCE DATA
Performance testing was conducted to ensure the safety and effectiveness of the device with the minor design changes demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed.
Biocompatibility Testing
The INFINITI Ambi Catheter is an externally communicating device with limited contact duration (≤ 24 hours) in contact with circulating blood. Biocompatibility testing, Chemical Characterization, and Toxicological Risk Assessment on the patient contacting portions of predicate device INFINITI 5F were performed Testing was performed to meet the endpoints for evaluation from ISO 10993-1:2018 and FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on September 4, 2020. Endpoints evaluated are as follows:
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Image /page/8/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The font appears to be italicized and has a slight curve to it. A registered trademark symbol is located to the bottom right of the word.
- Physical and/or Chemical Information .
- . Cytotoxicity - MEM Elution
- Sensitization – Guinea Pig Maximization
- Intracutaneous Irritation Reactivity
- . Acute Systemic Toxicity
- Material Mediated Pyrogenicity ●
- Hemocompatibility ●
Sterilization
The sterilization conditions have been validated according to ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices to provide a sterility assurance level (SAL) of 10°.
Ethylene oxide and ethylene chlorohydrin residuals meet requirements for limited exposure devices (contact