(28 days)
Not Found
No
The document describes a physical medical device (a guide catheter) and its mechanical features. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a guide catheter designed to provide access and serve as a conduit for other devices and fluids, rather than directly treating a disease or condition.
No
The device is described as a guide catheter designed to provide access to the venous system of the heart and serve as a conduit for other devices and fluids. It does not mention any function for analyzing or interpreting data to diagnose a condition.
No
The device description clearly outlines physical components such as a braided shaft, soft tip, coatings, marker bands, hub, and accessories, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device designed for intracardiac access and serving as a conduit for delivering devices and fluids within the venous system of the heart. This is an invasive medical device used directly within the body.
- Device Description: The description details the physical components and features of a catheter designed for insertion into the body, including a shaft, tip, hub, and accessories for assisting insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis of biological samples.
The device described is a catheter, which is a type of medical device used for accessing and delivering substances or other devices within the body. This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The CPS Direct™ Universal slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and other devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, the CPS Direct Universal slittable outer quide catheters can work with inner catheters as a system.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The device description of the CPS Direct™ Universal slittable outer guide catheter, 3D, is as follows.
· The CPS Direct™ Universal slittable outer quide catheter lead delivery during cardiac resynchronization therapy (CRT) procedures. The CPS Direct Universal provides access to the coronary venous system and acts as a conduit for contrast medium. The key design features of the CPS Direct™ Universal sittable outer quide catheter, 3D, has only undergone minimal changes to the shaft length, the curve design, and the package tray configuration. The diator packaged with the catheter has undergone a change in shaft length to accommodate the shaft length of the 3D catheter. The accessories listed in the device instructions for use have not changed. The key design features of the catheter are listed below:
- · Braid reinforced, varying durometer PEBAX shaft with molded proximal hub.
- · Atraumatic distal soft tip.
- · The outside surface and inside surfaces of the catheter shaft are coated with Siloxane to provide lubricity during use.
- · The distal end of the shaft has gold marker bands and tungsten stripes for fluoroscopic visibility.
- · Hub contains a sideport with extension tubing for contrast delivery, aspiration, or saline flush using a 3-way stopcock.
- · Accessories such as VBT used to assist the insertion of Abbott Devices (leads, quidewires, inner catheters, etc)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visibility mentioned in device description.
Anatomical Site
Intracardiac access of the venous system of the heart.
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 modifications to the CPS Direct™ Universal 3D sittable outer quide catheter and packaging, i.e., catheter length, catheter curve shape, and packaging tray, necessitated limited functional and packaging design verification (DV) testing, compatibility testing, and a sterilization adoption assessment study. Completion of all verification activities demonstrated that the modified catheter with associated components meets its predetermined design and that the subject CPS Direct™ Universal sittable outer quide catheter model DS2C029 (3D curve) is substantially equivalent to the predicate device.
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
§ 870.1250 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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a symbol with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
June 2nd, 2023
Abbott Medical Mary Adams Regulatory Affairs Consultant 15900 Valley View Court Sylmar, California 91342
Re: K231311
Trade/Device Name: CPS Direct™ Universal slittable outer guide catheter (DS2C029) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 5, 2023 Received: May 5, 2023
Dear Mary Adams:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Image /page/1/Picture/5 description: The image shows a digital signature. The name "Lydia S. Glaw -S" is written in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Lydia S. Glaw -S Date: 2023.06.02 12:11:54 -04'00'" is written in a smaller font.
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
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
CPS Direct™ Universal slittable outer quide catheter (DS2C029)
Indications for Use (Describe)
The CPS Direct™ Universal slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and other devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, the CPS Direct Universal slittable outer quide catheters can work with inner catheters as a system.
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
Prepared on: 2023-05-05
| Contact Details |
|---|
| ----------------- |
21 CFR 807.92(a)(1)
| Applicant Name | Abbott Medical | |
|---|---|---|
| Applicant Address | 15900 Valley View Court Sylmar CA 91342 United States | |
| Applicant Contact Telephone | (909) 991-5235 | |
| Applicant Contact | Ms. Mary Adams | |
| Applicant Contact Email | mary.adams2@abbott.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | CPS Direct ™ Universal slittable outer guide catheter (DS2C029) | |
| Common Name | Percutaneous catheter | |
| Classification Name | Catheter, Percutaneous | |
| Regulation Number | 870.1250 | |
| Product Code | DQY | |
| Legally Marketed Predicate Devices | ||
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K130257 | CPS Direct ™ Universal Slittable Outer Catheter | DQY |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The device description of the CPS Direct™ Universal slittable outer guide catheter, 3D, is as follows.
· The CPS Direct™ Universal slittable outer quide catheter lead delivery during cardiac resynchronization therapy (CRT) procedures. The CPS Direct Universal provides access to the coronary venous system and acts as a conduit for contrast medium. The key design features of the CPS Direct™ Universal sittable outer quide catheter, 3D, has only undergone minimal changes to the shaft length, the curve design, and the package tray configuration. The diator packaged with the catheter has undergone a change in shaft length to accommodate the shaft length of the 3D catheter. The accessories listed in the device instructions for use have not changed. The key design features of the catheter are listed below:
- · Braid reinforced, varying durometer PEBAX shaft with molded proximal hub.
- · Atraumatic distal soft tip.
- · The outside surface and inside surfaces of the catheter shaft are coated with Siloxane to provide lubricity during use.
- · The distal end of the shaft has gold marker bands and tungsten stripes for fluoroscopic visibility.
- · Hub contains a sideport with extension tubing for contrast delivery, aspiration, or saline flush using a 3-way stopcock.
- · Accessories such as VBT used to assist the insertion of Abbott Devices (leads, quidewires, inner catheters, etc)
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
The CPS Direct™ Universal slittable outer guide catheter is designed for intracardiac access of the heart and to serve as a conduit during implantation for the delium and other devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. In addition, the CPS Direct Universal slittable outer quide catheters can work with inner catheters as a system.
Indications for Use Comparison
4
The subject device CPS Direct™ Universal slittable outer guide catheter model DS2C029 (3D curve) has the following similarities to the predicate device model (DS2C029 extra wide curve) which previously received 510(k) concurrence (K130257):
- · Has the same indicated use,
- · Has the same fundamental scientific technology,
- · Incorporates the same basic catheter design,
- · Incorporates the same catheter construction,
- · Incorporates the same device and packaging materials, including sterile barrier,
- · Is sterilized using the same processes (EtO with SAL of at least 10^-6 per ISO 11135-1).
In summary, the CPS Direct Universal slittable outer guide catheter model DS2C029 (3D curve) described in this submission is substantially equivalent to the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The subject CPS Direct™ Universal slittable outer quide catheter model DS2C029 (3D curve) has the same technological characteristics as the currently marketed CPS Direct™ Universal slittable outer guide catheter model DS2C029 (X-Wide curve), with only minimal changes to the catheter, dilator and packaging design, and meets current regulatory requirements and standards.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The modifications to the CPS Direct™ Universal 3D sittable outer quide catheter and packaging, i.e., catheter length, catheter curve shape, and packaging tray, necessitated limited functional and packaging design verification (DV) testing, compatibility testing, and a sterilization adoption assessment study. Completion of all verification activities demonstrated that the modified catheter with associated components meets its predetermined design and that the subject CPS Direct™ Universal sittable outer quide catheter model DS2C029 (3D curve) is substantially equivalent to the predicate device.