(28 days)
Not Found
Not Found
No
The summary describes a physical catheter delivery system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is a delivery system intended to provide vascular access and serve as a conduit for other devices, not to directly treat a medical condition.
No
The device description states its purpose is to "provide vascular access... and serve as a conduit for the delivery and support of other devices," which indicates an interventional and supportive function rather than a diagnostic one.
No
The device description explicitly lists multiple hardware components (Peelable Introducer Sheath, Dilator, Cannulator, Detachable Hemostasis Valve with Side Port, Guidewire, Syringe and Needle).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide vascular access and serve as a conduit for delivering other devices. This is a direct medical intervention on the patient's body.
- Device Description: The components listed (sheath, dilator, valve, guidewire, etc.) are all instruments used for accessing and manipulating the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly access or treat the body itself. This device is clearly designed for direct patient intervention.
N/A
Intended Use / Indications for Use
The Apeel CS Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.
Product codes
DYB
Device Description
The Apeel™ CS Catheter Delivery System includes a Peelable Introducer Sheath, Dilator, Cannulator, Detachable Hemostasis Valve with Side Port, Guidewire, Syringe and Needle. The introducer kits are provided sterile, and are intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access including the coronary sinus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Seal-Away CS Introducer Kit, Seal-Away Hemostasis Adapter, and Alliance Catheter Delivery System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
A.
B.
510(k) Summary (As required by 21 CFR 807.92)
| Submitter Information | JUL 1 8 2003 |
|---|---|
| Submitter's Name: | St. Jude Medical, Daig Division |
| Address: | 14901 DeVeau Place |
| Minnetonka, Minnesota 55345-2126 U.S.A. | |
| Telephone Number: | (952) 351-1453 |
| Contact Person: | Mike Burnside |
| Date Submission Prepared: | 19-June-2003 |
| Device Information | |
| Trade Name: | ApeelTM CS Catheter Delivery System |
| Common or Usual Name: | Percutaneous Catheter Introducer |
| Classification Name: | Percutaneous Catheter Introducer (per 21 CFR Part |
| 870.1340) | |
| Device Classification: | Class II (per 21 CFR Part 870.1340) |
| Panel - Cardiovascular | |
| Predicate Devices: | Seal-Away CS Introducer Kit, |
| Seal-Away Hemostasis Adapter, and | |
| Alliance Catheter Delivery System | |
| St. Jude Medical, Daig Division | |
| Device Description: | The Apeel™ CS Catheter Delivery System includes a |
| Peelable Introducer Sheath, Dilator, Cannulator, | |
| Detachable Hemostasis Valve with Side Port, | |
| Guidewire, Syringe and Needle. The introducer kits are | |
| provided sterile, and are intended for single-use only. | |
| Intended Use: | The Apeel CS Catheter Delivery System is intended |
| to provide vascular access including the coronary | |
| sinus and serve as a conduit for the delivery and | |
| support of other devices where minimizing blood | |
| loss is essential. |
C. Comparison of Required Technological Characteristics
All technological characteristics of the Apeel™ CS Catheter Delivery System are substantially equivalent to the predicate devices including product design, packaging, sterilization, and labeling.
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D. Support of the Substantial Equivalence
St. Jude Medical, Daig Division considers the Apeel CS Catheter Delivery System to be substantially equivalent to the predicate devices.
ir
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's emblem, which features a stylized caduceus-like symbol with three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
St. Jude Medical c/o Mike Burnside 14901 Deveau Place Minnetonka, MN 553452
Re: K031906
Apeel CS Catheter Delivery System Regulation Number: 870.1340 Regulation Name: Percutaneous Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 19, 2003 Received: June 20, 2003
Dear Mr. Burnside:
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.
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
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Page 2 - Mike Burnside
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 Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Oerle Tu
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Apeel™ CS Catheter Delivery System_ Device Name:
Indications for Use:
The Apeel CS Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K031906 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|