(448 days)
Not Found
No
The summary describes a reprocessed catheter and its performance testing, with no mention of AI or ML capabilities.
No
The device is designed to deliver contrast medium for diagnostic imaging, not to treat a condition or disease.
No
Explanation: The device is described as delivering contrast medium to selected sites in the vascular system, which is a procedural/interventional function, not a diagnostic one. There is no mention of it being used to identify or characterize a disease or condition.
No
The device description and performance studies clearly indicate this is a physical catheter, not a software-only device. The testing focuses on hardware aspects like biocompatibility, cleaning, sterilization, and functional testing of the physical catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver radiopaque contrast medium to selected sites in the vascular system." This is a direct intervention within the body for imaging purposes, not a test performed on samples taken from the body.
- Device Description: The description of a catheter designed for insertion into the vascular system aligns with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate imaging within the body, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
Product codes (comma separated list FDA assigned to the subject device)
NLI
Device Description
The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body. The item numbers included in the scope of this submission are as follows: [table of item numbers, French sizes, lengths, side holes, and curves is provided across several pages and is too extensive to transcribe here, but includes models under "Reprocessed Cordis Super Torque Diagnostic Angiographic Catheter" and "Reprocessed Cordis Super Torque Plus Diagnostic Angiographic Catheter."]
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
Bench and laboratory testing was conducted to demonstrate substantially equivalent performance of the Reprocessed Cordis Super Torque and Super Torque Plus Catheters. This included the following:
- Biocompatibility
- Cytotoxicity
- Hemocompatibility
- Sensitization
- Irritation
- Systemic Toxicitv
- Cleaning Validation
- Sterilization Validation
- Functional testing
- Visual Inspection
- Dimensional Verification
- Radiopacity Testing
- Simulated Use Testing
- Leak Testing
- Torsion Testing
- Tip Buckling Testing
- Tensile Testing
- Coating Coverage
- Particulate Testing
- Packaging Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2024
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257
Re: K231015
Trade/Device Name: Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLI Dated: April 7, 2023 Received: April 10, 2023
Dear Amanda Babcock:
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.
1
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).
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 medical devices and radiation-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,
Digitally signed by Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.07.01 09:21:23 shakoor -S -04'00'
For
Gregory O'Connell
2
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
3
Indications for Use
510(k) Number (if known) K231015
Device Name
Reprocessed Cordis Super Torque and Super Torque Plus Angiographic Diagnostic Catheters
Indications for Use (Describe)
Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Meerna Muradvich Regulatory Affairs Engineer Innovative Health, LLC. (480) 692-7176 (office) (888) 965-7706 (fax) mmuradvich@innovative-health.com
Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7706 (fax) ababcock@innovative-health.com
Date prepared:
06/26/2024
Device Information:
| Trade/Proprietary Name: | Reprocessed Cordis Super Torque and Super
Torque Plus Diagnostic Angiographic Catheters |
|-------------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Angiographic Catheter |
| Classification Name: | Catheter, Angiography, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.1200 |
| Product Code: | NLI |
Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K915836 | Cordis 5.0 French Super Torque Catheters | Cordis Corp. |
| K914007 | Cordis 5.2 French Super Torque Plus | Cordis Corp. |
Device Description:
The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.
The item numbers included in the scope of this submission are as follows:
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
|--------------------------------------------------------------------------------------|----------------|----------------|--------|---------------|---------------------------------------------|
| | 532-410T | 4 | 65 | 8 | PIG |
| | 532-420T | 4 | 65 | 8 | straight |
| | 532-462 | 4 | 65 | 2 | RDCS |
| Description | Item Number | French Size | Length | Side holes | Curve |
| Reprocessed
Cordis Super
Torque
Diagnostic
Angiographic
Catheter | 532-444 | 4 | 65 | 0 | C3 |
| | 532-445 | 4 | 65 | 2 | C3 |
| | 532-473 | 4 | 65 | 0 | SHK 1 |
| | 532-474 | 4 | 65 | 0 | SHK 2 |
| | 532-447 | 4 | 65 | 0 | JC 1 |
| | 532-448 | 4 | 65 | 0 | JC 2 |
| | 532-449 | 4 | 65 | 0 | JC 3 |
| | SR3740 | 4 | 80 | 0 | JL 1.5 |
| | SRD6054 | 4 | 80 | 0 | JL 2 |
| | SR4533 | 4 | 80 | 0 | JL 2.5 |
| | SRD6920 | 4 | 80 | 4 | PIG 145° |
| | 532-432 | 4 | 80 | 2 | multipurpose small |
| | 532-478 | 4 | 80 | 2 | RDCS |
| | 532-411T | 4 | 90 | 8 | PIG |
| | 532-421T | 4 | 90 | 8 | straight |
| | SRD5816 | 4 | 100 | 0 | IM-MOD-5 |
| | 532-412T | 4 | 100 | 8 | PIG |
| | 532-422T | 4 | 100 | 8 | straight |
| | 532-430 | 4 | 100 | 0 | multipurpose small |
| | 532-482 | 4 | 100 | 2 | multipurpose small |
| | 532-414 | 4 | 100 | 0 | SIM 1 |
| | 532-415 | 4 | 100 | 0 | SIM 2 |
| | 532-461 | 4 | 100 | 0 | H1 |
| | 532-470 | 4 | 100 | 0 | MAN |
| | 532-405 | 4 | 100 | 0 | BERN |
| | 532-436 | 4 | 100 | 0 | JB1 |
| | 532-437 | 4 | 100 | 0 | JB2 |
| | 532-438 | 4 | 100 | 0 | JB3 |
| | 532-497 | 4 | 100 | 0 | VERT |
| | 532-413T | 4 | 110 | 8 | PIG |
| | 532-524V8 | 5 | 65 | 8 | PIG |
| | 532-564V8 | 5 | 65 | 8 | straight |
| | 532-576 | 5 | 65 | 0 | multipurpose (subintimal
recanalization) |
| | 532-510 | 5 | 65 | 2 | RDCS |
| | 532-514 | 5 | 65 | 0 | C3 |
| | 532-517 | 5 | 65 | 2 | C3 |
| | 532-519 | 5 | 65 | 0 | SHK 1 |
| | 532-522 | 5 | 65 | 0 | JC 2 |
| | 532-523 | 5 | 65 | 0 | JC 3 |
| | 532-579 | 5 | 80 | 0 | MPA |
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
| | 532-511 | 5 | 80 | 2 | RDCS |
| | 532-509 | 5 | 80 | 0 | RDCA |
| | 532-567 | 5 | 80 | 0 | SHK 2 |
| | 532-539F8 | 5 | 90 | 8 | PIG |
| | 532-555H8 | 5 | 100 | 8 | PIG |
| | 532-569H8 | 5 | 100 | 8 | straight |
| | 532-578 | 5 | 100 | 0 | MPA |
| | 532-501 | 5 | 100 | 0 | SIM 1 |
| | 532-546 | 5 | 100 | 2 | SIM 1 |
| | 532-502 | 5 | 100 | 0 | SIM 2 |
| | 532-547 | 5 | 100 | 2 | SIM 2 |
| | 532-503 | 5 | 100 | 0 | SIM 3 |
| | 532-504 | 5 | 100 | 0 | H1 |
| | 532-520 | 5 | 100 | 0 | HN4 |
| | 532-571 | 5 | 100 | 0 | MAN |
| Reprocessed | 532-541H0 | 5 | 100 | 0 | JB1 |
| Cordis Super | 532-543H0 | 5 | 100 | 0 | JB2 |
| Torque | 532-549H0 | 5 | 100 | 0 | VERT |
| Diagnostic | 455-610T | 6 | 65 | 12 | PIG |
| Angiographic
Catheter | 455-672 | 6 | 65 | 0 | C3 |
| | 455-689 | 6 | 80 | 2 | RDCA |
| | 455-698 | 6 | 80 | 4 | NIH |
| | 532-506 | 6 | 80 | 2 | multipurpose small |
| | 455-623 | 6 | 80 | 0 | MPA |
| | 455-636 | 6 | 80 | 2 | MPA |
| | 455-686 | 6 | 80 | 0 | RDCA |
| | 455-611T | 6 | 90 | 12 | PIG |
| | 532-618 | 6 | 100 | 0 | JL 3.5 |
| | 532-620 | 6 | 100 | 0 | JL 4 |
| | 532-627 | 6 | 100 | 0 | JL 4.5 |
| | 532-622 | 6 | 100 | 0 | JL 5 |
| | 532-624 | 6 | 100 | 0 | JL 6 |
| | 532-645 | 6 | 100 | 0 | AL 1 |
| | 532-646 | 6 | 100 | 0 | AL 2 |
| | 532-647 | 6 | 100 | 0 | AL 3 |
| | 532-619 | 6 | 100 | 0 | JR 3.5 |
| | 532-621 | 6 | 100 | 0 | JR 4 |
| | 532-623 | 6 | 100 | 0 | JR 5 |
| | 532-625 | 6 | 100 | 0 | JR 6 |
| | 532-648 | 6 | 100 | 0 | AR MOD |
| | 532-642 | 6 | 100 | 2 | MPA 2 |
| Description | ltem
Number | French
Size | Length | Side
holes | Curve |
| | 532-649 | ర్ | 100 | 2 | MPB 2 |
| | 532-640 | 6 | 100 | 0 | SON 1 |
| | 532-664 | 6 | 100 | 4 | SON 2 |
| | 532-672 | 6 | 100 | 0 | LCB |
| | 532-670 | ರಿ | 100 | 0 | RCB |
| | 532-660 | 6 | 100 | 0 | IM |
| Reprocessed | 455-637 | 6 | 100 | 2 | MPA |
| Cordis Super | 455-660 | 6 | 100 | 0 | SIM 1 |
| Torque | 455-660D | 6 | 100 | 2 | SIM 1 |
| Diagnostic | 455-661 | 6 | 100 | 0 | SIM 2 |
| Angiographic | 455-662 | 6 | 100 | 0 | ടിM 3 |
| Catheter | 455-663 | 6 | 100 | 0 | SIM 4 |
| | 455-665 | 6 | 100 | 0 | H1 |
| | 455-666 | 6 | 100 | 0 | H1 |
| | 532-650S | 6 | 110 | 6 | PIG |
| | 532-652S | 6 | 110 | 6 | PIG 145° |
| | 532-654S | ರಿ | 110 | 6 | PIG 145° MOD |
| | 455-613E | රි | 110 | 8 | PIG |
| Reprocessed | 533-562 | 5.2 | 65 | 2 | MPA 2 |
| Cordis Super | 533-579 | 5.2 | 80 | 0 | MPA |
| Torque Plus
Diagnostic | SR3216 | 5.2 | 100 | 0 | JL 3 |
| Angiographic | 533-551 | 5.2 | 100 | 0 | JL 3.5 |
| Catheter | 233-223 | 5.2 | 100 | 0 | JL 4 |
| | 533-527 | 5.2 | 100 | 0 | JL 4.5 |
| | 233-229 | 5.2 | 100 | 0 | ി 5 |
| | 533-561 | 5.2 | 100 | 0 | JL 6 |
| | 533-542 | 5.2 | 100 | 0 | AL 2 |
| | 533-544 | 5.2 | 100 | O | AL 3 |
| | SR4615 | 5.2 | 100 | O | XB 3.5 ST |
| | 233-250 | 5.2 | 100 | O | JR 3.5 |
| | 533-552 | 5.2 | 100 | O | JR 4 |
| | 533-528 | 5.2 | 100 | 0 | JR 4 MOD |
| | 533-563 | 5.2 | 100 | 0 | JR 4 ST |
| | 533-558 | 5.2 | 100 | 0 | JR 5 |
| | 533-560 | 5.2 | 100 | O | JR 6 |
| | SR1924 | 5.2 | 100 | O | MPA |
| | 533-582 | 5.2 | 100 | 2 | MPA 2 |
| | 533-584 | 5.2 | 100 | O | CAS 1 |
| | 533-585 | 5.2 | 100 | 0 | CAS 2 |
| | 59950072 | 5.2 | 100 | 2 | RBL-JK |
| | 599500T1 | 5.2 | 100 | 1 | RBL-TG |
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
| | 533-572 | 5.2 | 100 | 0 | LCB |
| | 533-570 | 5.2 | 100 | 0 | RCB |
| | 533-580 | 5.2 | 100 | 0 | IM |
| | SR4658 | 5.2 | 100 | 0 | IM-MOD |
| | SR4268 | 5.2 | 100 | 0 | IM-MOD-2 |
| | SR4685 | 5.2 | 100 | 0 | IM-MOD-3 |
| | 533-533 | 5.2 | 110 | 6 | PIG |
| | 533-534A | 5.2 | 110 | 6 | PIG 145° |
| Reprocessed
Cordis Super
Torque Plus
Diagnostic
| 533-537S | 5.2 | 110 | 6 | PIG 145° MOD |
| | 533-533A | 5.2 | 110 | 6 | PIG 155° |
| | 533-633 | 6 | 80 | 0 | MPA 1 |
| | 533-629 | 6 | 80 | 2 | MPA 2 |
| | 533-682 | 6 | 80 | 4 | CAS 2 |
| | 533-635 | 6 | 80 | 0 | NIH |
| | 533-618 | 6 | 100 | 0 | JL 3.5 |
| | 533-620 | 6 | 100 | 0 | JL 4 |
| | 533-627 | 6 | 100 | 0 | JL 4.5 |
| | 533-622 | 6 | 100 | 0 | JL 5 |
| | 533-624 | 6 | 100 | 0 | JL 6 |
| | 533-645 | 6 | 100 | 0 | AL 1 |
| | 533-646 | 6 | 100 | 0 | AL 2 |
| | 533-647 | 6 | 100 | 0 | AL 3 |
| | 533-619 | 6 | 100 | 0 | JR 3.5 |
| | 533-621 | 6 | 100 | 2 | JR 3.5 |
| | 533-687 | 6 | 100 | 0 | JR 4 CLASSIC |
| | 533-689 | 6 | 100 | 0 | JR 4 RECESSED
BRAIDING |
| | 533-628 | 6 | 100 | 0 | JR 4 MOD |
| | 533-626 | 6 | 100 | 0 | JR 4 ST |
| | 533-623 | 6 | 100 | 0 | JR 5 |
| | 533-625 | 6 | 100 | 0 | JR 6 |
| | 533-648 | 6 | 100 | 0 | AR MOD |
| | 533-641 | 6 | 100 | 0 | AR 1 MOD |
| | 533-643 | 6 | 100 | 0 | AR 2 MOD |
| | 533-640 | 6 | 100 | 0 | MPA 1 COURNAD |
| | 533-642 | 6 | 100 | 2 | MPA 2 |
| | 533-649 | 6 | 100 | 2 | MPB 2 |
| | 533-634 | 6 | 100 | 6 | MPB 3 |
| | 533-630 | 6 | 100 | 4 | SON 1 |
| | 533-631 | 6 | 100 | 0 | SON 2 |
| | 533-632 | 6 | 100 | 4 | SON 3 |
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
| Reprocessed
Cordis Super
Torque Plus
Diagnostic
Angiographic
Catheter | 533-684 | 6 | 100 | 0 | CAS 1 |
| | 533-685 | 6 | 100 | 0 | CAS 2 |
| | 533-686 | 6 | 100 | 0 | CAS 3 |
| | 599600R401 | 6 | 100 | 1 | RBL 4.0 |
| | 599600R451 | 6 | 100 | 1 | RBL 4.5 |
| | 599600R501 | 6 | 100 | 1 | RBL 5.0 |
| | 599600J2 | 6 | 100 | 2 | RBL-JK |
| | 599600T1 | 6 | 100 | 1 | RBL-TG |
| | 533-637 | 6 | 100 | 0 | EGB 1 |
| | 533-638 | 6 | 100 | 0 | EGB 2 |
| | 533-672 | 6 | 100 | 0 | LCB |
| | 533-670 | 6 | 100 | 0 | RCB |
| | 533-660 | 6 | 100 | 0 | IM |
| | 533-636 | 6 | 100 | 0 | NIH |
| | 533-650F | 6 | 110 | 4 | PIG |
| | 533-650S | 6 | 110 | 6 | PIG |
| | 533-650E | 6 | 110 | 8 | PIG |
| | 533-652S | 6 | 110 | 6 | PIG 145° |
| | 533-653S | 6 | 110 | 6 | PIG 145° MOD |
| | 533-654S | 6 | 110 | 6 | PIG 155° |
| | 533-655S | 6 | 110 | 6 | PIG 155° MOD |
5
6
7
8
9
Table 1: Device Scope
Indications for Use:
Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Cordis Super Torque and Super Torque Plus diagnostic angiographic catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate substantially equivalent performance of the Reprocessed Cordis Super Torque and Super Torque Plus Catheters. This included the following:
10
- Biocompatibility ●
- Cytotoxicity .
- Hemocompatibility
- Sensitization
- . Irritation
- . Systemic Toxicitv
- Cleaning Validation ●
- Sterilization Validation
- Functional testing ●
- Visual Inspection .
- . Dimensional Verification
- l Radiopacity Testing
- l Simulated Use Testing
- . Leak Testing
- I Torsion Testing
- Tip Buckling Testing I
- 트 Tensile Testing
- . Coating Coverage
- . Particulate Testing
- . Packaging Validation
The Reprocessed Cordis Super Torque and Super Torque Plus Catheters are reprocessed no more than one (1) time. Each device is marked, serialized and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic catheters do not raise new questions of safety and effectiveness and supports substantial equivalence to the predicate devices described herein.
11
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
|--------------------------------------------------------------------------------------|----------------|----------------|--------|---------------|---------------------------------------------|
| | 532-410T | 4 | 65 | 8 | PIG |
| | 532-420T | 4 | 65 | 8 | straight |
| | 532-462 | 4 | 65 | 2 | RDCS |
| | 532-444 | 4 | 65 | 0 | C3 |
| | 532-445 | 4 | 65 | 2 | C3 |
| | 532-473 | 4 | 65 | 0 | SHK 1 |
| | 532-474 | 4 | 65 | 0 | SHK 2 |
| | 532-447 | 4 | 65 | 0 | JC 1 |
| | 532-448 | 4 | 65 | 0 | JC 2 |
| | 532-449 | 4 | 65 | 0 | JC 3 |
| | SR3740 | 4 | 80 | 0 | JL 1.5 |
| | SRD6054 | 4 | 80 | 0 | JL 2 |
| | SR4533 | 4 | 80 | 0 | JL 2.5 |
| | SRD6920 | 4 | 80 | 4 | PIG 145° |
| | 532-432 | 4 | 80 | 2 | multipurpose small |
| | 532-478 | 4 | 80 | 2 | RDCS |
| | 532-411T | 4 | 90 | 8 | PIG |
| | 532-421T | 4 | 90 | 8 | straight |
| Reprocessed
Cordis Super
Torque
Diagnostic
Angiographic
Catheter | SRD5816 | 4 | 100 | 0 | IM-MOD-5 |
| | 532-412T | 4 | 100 | 8 | PIG |
| | 532-422T | 4 | 100 | 8 | straight |
| | 532-430 | 4 | 100 | 0 | multipurpose small |
| | 532-482 | 4 | 100 | 2 | multipurpose small |
| | 532-414 | 4 | 100 | 0 | SIM 1 |
| | 532-415 | 4 | 100 | 0 | SIM 2 |
| | 532-461 | 4 | 100 | 0 | H1 |
| | 532-470 | 4 | 100 | 0 | MAN |
| | 532-405 | 4 | 100 | 0 | BERN |
| | 532-436 | 4 | 100 | 0 | JB1 |
| | 532-437 | 4 | 100 | 0 | JB2 |
| | 532-438 | 4 | 100 | 0 | JB3 |
| | 532-497 | 4 | 100 | 0 | VERT |
| | 532-413T | 4 | 110 | 8 | PIG |
| | 532-524V8 | 5 | 65 | 8 | PIG |
| | 532-564V8 | 5 | 65 | 8 | straight |
| | 532-576 | 5 | 65 | 0 | multipurpose (subintimal
recanalization) |
| | 532-510 | 5 | 65 | 2 | RDCS |
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
| | 532-514 | 5 | 65 | 0 | C3 |
| | 532-517 | 5 | 65 | 2 | C3 |
| | 532-519 | 5 | 65 | 0 | SHK 1 |
| | 532-522 | 5 | 65 | 0 | JC 2 |
| | 532-523 | 5 | 65 | 0 | JC 3 |
| | 532-579 | 5 | 80 | 0 | MPA |
| | 532-511 | 5 | 80 | 2 | RDCS |
| | 532-509 | 5 | 80 | 0 | RDCA |
| | 532-567 | 5 | 80 | 0 | SHK 2 |
| | 532-539F8 | 5 | 90 | 8 | PIG |
| | 532-555H8 | 5 | 100 | 8 | PIG |
| | 532-569H8 | 5 | 100 | 8 | straight |
| | 532-578 | 5 | 100 | 0 | MPA |
| | 532-501 | 5 | 100 | 0 | SIM 1 |
| | 532-546 | 5 | 100 | 2 | SIM 1 |
| | 532-502 | 5 | 100 | 0 | SIM 2 |
| | 532-547 | 5 | 100 | 2 | SIM 2 |
| | 532-503 | 5 | 100 | 0 | SIM 3 |
| | 532-504 | 5 | 100 | 0 | H1 |
| | 532-520 | 5 | 100 | 0 | HN4 |
| Reprocessed
Cordis Super
Torque
Diagnostic
Angiographic
Catheter | 532-571 | 5 | 100 | 0 | MAN |
| | 532-541H0 | 5 | 100 | 0 | JB1 |
| | 532-543H0 | 5 | 100 | 0 | JB2 |
| | 532-549H0 | 5 | 100 | 0 | VERT |
| | 455-610T | 6 | 65 | 12 | PIG |
| | 455-672 | 6 | 65 | 0 | C3 |
| | 455-689 | 6 | 80 | 2 | RDCA |
| | 455-698 | 6 | 80 | 4 | NIH |
| | 532-506 | 6 | 80 | 2 | multipurpose small |
| | 455-623 | 6 | 80 | 0 | MPA |
| | 455-636 | 6 | 80 | 2 | MPA |
| | 455-686 | 6 | 80 | 0 | RDCA |
| | 455-611T | 6 | 90 | 12 | PIG |
| | 532-618 | 6 | 100 | 0 | JL 3.5 |
| | 532-620 | 6 | 100 | 0 | JL 4 |
| | 532-627 | 6 | 100 | 0 | JL 4.5 |
| | 532-622 | 6 | 100 | 0 | JL 5 |
| | 532-624 | 6 | 100 | 0 | JL 6 |
| | 532-645 | 6 | 100 | 0 | AL 1 |
| | 532-646 | 6 | 100 | 0 | AL 2 |
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
| Reprocessed
Cordis Super
Torque
Diagnostic
Angiographic
Catheter | 532-647 | 6 | 100 | 0 | AL 3 |
| | 532-619 | 6 | 100 | 0 | JR 3.5 |
| | 532-621 | 6 | 100 | 0 | JR 4 |
| | 532-623 | 6 | 100 | 0 | JR 5 |
| | 532-625 | 6 | 100 | 0 | JR 6 |
| | 532-648 | 6 | 100 | 0 | AR MOD |
| | 532-642 | 6 | 100 | 2 | MPA 2 |
| | 532-649 | 6 | 100 | 2 | MPB 2 |
| | 532-640 | 6 | 100 | 0 | SON 1 |
| | 532-664 | 6 | 100 | 4 | SON 2 |
| | 532-672 | 6 | 100 | 0 | LCB |
| | 532-670 | 6 | 100 | 0 | RCB |
| | 532-660 | 6 | 100 | 0 | IM |
| | 455-637 | 6 | 100 | 2 | MPA |
| | 455-660 | 6 | 100 | 0 | SIM 1 |
| | 455-660D | 6 | 100 | 2 | SIM 1 |
| | 455-661 | 6 | 100 | 0 | SIM 2 |
| | 455-662 | 6 | 100 | 0 | SIM 3 |
| | 455-663 | 6 | 100 | 0 | SIM 4 |
| | 455-665 | 6 | 100 | 0 | H1 |
| | 455-666 | 6 | 100 | 0 | H1 |
| | 532-650S | 6 | 110 | 6 | PIG |
| | 532-652S | 6 | 110 | 6 | PIG 145° |
| | 532-654S | 6 | 110 | 6 | PIG 145° MOD |
| | 455-613E | 6 | 110 | 8 | PIG |
| Reprocessed
Cordis Super
Torque Plus
Diagnostic
Angiographic
Catheter | 533-562 | 5.2 | 65 | 2 | MPA 2 |
| | 533-579 | 5.2 | 80 | 0 | MPA |
| | SR3216 | 5.2 | 100 | 0 | JL 3 |
| | 533-551 | 5.2 | 100 | 0 | JL 3.5 |
| | 533-553 | 5.2 | 100 | 0 | JL 4 |
| | 533-527 | 5.2 | 100 | 0 | JL 4.5 |
| | 533-559 | 5.2 | 100 | 0 | JL 5 |
| | 533-561 | 5.2 | 100 | 0 | JL 6 |
| | 533-542 | 5.2 | 100 | 0 | AL 2 |
| | 533-544 | 5.2 | 100 | 0 | AL 3 |
| | SR4615 | 5.2 | 100 | 0 | XB 3.5 ST |
| | 533-550 | 5.2 | 100 | 0 | JR 3.5 |
| | 533-552 | 5.2 | 100 | 0 | JR 4 |
| | 533-528 | 5.2 | 100 | 0 | JR 4 MOD |
| | 533-563 | 5.2 | 100 | 0 | JR 4 ST |
| Description | Item Number | French Size | Length | Side holes | Curve |
| | 533-558 | 5.2 | 100 | 0 | JR 5 |
| | 533-560 | 5.2 | 100 | 0 | JR 6 |
| | SR1924 | 5.2 | 100 | 0 | MPA |
| | 533-582 | 5.2 | 100 | 2 | MPA 2 |
| | 533-584 | 5.2 | 100 | 0 | CAS 1 |
| | 533-585 | 5.2 | 100 | 0 | CAS 2 |
| | 599500J2 | 5.2 | 100 | 2 | RBL-JK |
| | 599500T1 | 5.2 | 100 | 1 | RBL-TG |
| | 533-572 | 5.2 | 100 | 0 | LCB |
| | 533-570 | 5.2 | 100 | 0 | RCB |
| | 533-580 | 5.2 | 100 | 0 | IM |
| | SR4658 | 5.2 | 100 | 0 | IM-MOD |
| | SR4268 | 5.2 | 100 | 0 | IM-MOD-2 |
| | SR4685 | 5.2 | 100 | 0 | IM-MOD-3 |
| | 533-533 | 5.2 | 110 | 6 | PIG |
| | 533-534A | 5.2 | 110 | 6 | PIG 145° |
| Reprocessed
Cordis Super
Torque Plus
Diagnostic
Angiographic
Catheter | 533-537S | 5.2 | 110 | 6 | PIG 145° MOD |
| | 533-533A | 5.2 | 110 | 6 | PIG 155° |
| | 533-633 | 6 | 80 | 0 | MPA 1 |
| | 533-629 | 6 | 80 | 2 | MPA 2 |
| | 533-682 | 6 | 80 | 4 | CAS 2 |
| | 533-635 | 6 | 80 | 0 | NIH |
| | 533-618 | 6 | 100 | 0 | JL 3.5 |
| | 533-620 | 6 | 100 | 0 | JL 4 |
| | 533-627 | 6 | 100 | 0 | JL 4.5 |
| | 533-622 | 6 | 100 | 0 | JL 5 |
| | 533-624 | 6 | 100 | 0 | JL 6 |
| | 533-645 | 6 | 100 | 0 | AL 1 |
| | 533-646 | 6 | 100 | 0 | AL 2 |
| | 533-647 | 6 | 100 | 0 | AL 3 |
| | 533-619 | 6 | 100 | 0 | JR 3.5 |
| | 533-621 | 6 | 100 | 2 | JR 3.5 |
| | 533-687 | 6 | 100 | 0 | JR 4 CLASSIC
JR 4 RECESSED |
| | 533-689 | 6 | 100 | 0 | BRAIDING |
| | 533-628 | 6 | 100 | 0 | JR 4 MOD |
| | 533-626 | 6 | 100 | 0 | JR 4 ST |
| | 533-623 | 6 | 100 | 0 | JR 5 |
| | 533-625 | 6 | 100 | 0 | JR 6 |
| | 533-648 | 6 | 100 | 0 | AR MOD |
| Description | Item
Number | French
Size | Length | Side
holes | Curve |
| Reprocessed
Cordis Super
Torque Plus
Diagnostic
Angiographic
Catheter | 533-641 | 6 | 100 | 0 | AR 1 MOD |
| | 533-643 | 6 | 100 | 0 | AR 2 MOD |
| | 533-640 | 6 | 100 | 0 | MPA 1 COURNAD |
| | 533-642 | 6 | 100 | 2 | MPA 2 |
| | 533-649 | 6 | 100 | 2 | MPB 2 |
| | 533-634 | 6 | 100 | 6 | MPB 3 |
| | 533-630 | 6 | 100 | 4 | SON 1 |
| | 533-631 | 6 | 100 | 0 | SON 2 |
| | 533-632 | 6 | 100 | 4 | SON 3 |
| | 533-684 | 6 | 100 | 0 | CAS 1 |
| | 533-685 | 6 | 100 | 0 | CAS 2 |
| | 533-686 | 6 | 100 | 0 | CAS 3 |
| | 599600R401 | 6 | 100 | 1 | RBL 4.0 |
| | 599600R451 | 6 | 100 | 1 | RBL 4.5 |
| | 599600R501 | 6 | 100 | 1 | RBL 5.0 |
| | 599600J2 | 6 | 100 | 2 | RBL-JK |
| | 599600T1 | 6 | 100 | 1 | RBL-TG |
| | 533-637 | 6 | 100 | 0 | EGB 1 |
| | 533-638 | 6 | 100 | 0 | EGB 2 |
| | 533-672 | 6 | 100 | 0 | LCB |
| | 533-670 | 6 | 100 | 0 | RCB |
| | 533-660 | 6 | 100 | 0 | IM |
| | 533-636 | 6 | 100 | 0 | NIH |
| | 533-650F | 6 | 110 | 4 | PIG |
| | 533-650S | 6 | 110 | 6 | PIG |
| | 533-650E | 6 | 110 | 8 | PIG |
| | 533-652S | 6 | 110 | 6 | PIG 145° |
| | 533-653S | 6 | 110 | 6 | PIG 145° MOD |
| | 533-654S | 6 | 110 | 6 | PIG 155° |
| | 533-655S | 6 | 110 | 6 | PIG 155° MOD |
The item numbers included in the scope of this submission are as follows:
12
13
14
15
Table 1: Device Scope