(28 days)
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.
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.
The provided text is a 510(K) summary for the Apeel™ CS Catheter Delivery System, a medical device. This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed performance studies with acceptance criteria in the manner one might find for a diagnostic or AI-powered device.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted from this document. The document explicitly states:
- "All technological characteristics of the Apeel™ CS Catheter Delivery System are substantially equivalent to the predicate devices including product design, packaging, sterilization, and labeling."
- "St. Jude Medical, Daig Division considers the Apeel CS Catheter Delivery System to be substantially equivalent to the predicate devices."
This indicates that the primary "proof" of the device's acceptability is its similarity to already approved devices, not necessarily a standalone performance study against specific, quantified acceptance criteria.
However, I can provide a table summarizing what might be considered "acceptance criteria" based on the substantial equivalence claim, and state why the other requested information is not available in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use | Intended to provide vascular access (including coronary sinus) and serve as a conduit for other devices, minimizing blood loss. (Matches predicate devices' intended use). |
| Technological Characteristics | Substantially equivalent to predicate devices (Seal-Away CS Introducer Kit, Seal-Away Hemostasis Adapter, and Alliance Catheter Delivery System) in product design, packaging, sterilization, and labeling. |
| Safety and Effectiveness | Deemed safe and effective based on substantial equivalence to predicate devices, which are legally marketed. |
| Classification | Class II (Percutaneous Catheter Introducer, per 21 CFR 870.1340). (Matches predicate device classification). |
| Sterility | Provided sterile. (Implies adherence to predicate device's sterility methods and successful sterilization). |
| Single-Use | Intended for single-use only. (Matches predicate device usage). |
Information Not Available in the Provided Document:
The provided 510(K) summary does not contain the following details, as it focuses on substantial equivalence rather than a de novo performance study with specific quantifiable metrics. This kind of information is typically found in clinical study reports or detailed engineering verification/validation reports, which are not usually part of the public 510(K) summary.
- 2. Sample size used for the test set and the data provenance: Not applicable/not provided for this type of submission. There is no "test set" in the context of a performance study described here.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth is not established in this context.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an introducer sheath, not an AI or diagnostic imaging device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided.
- 8. The sample size for the training set: Not applicable/not provided.
- 9. How the ground truth for the training set was established: Not applicable/not provided.
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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 PlaceMinnetonka, 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 Part870.1340) |
| Device Classification: | Class II (per 21 CFR Part 870.1340)Panel - Cardiovascular |
| Predicate Devices: | Seal-Away CS Introducer Kit,Seal-Away Hemostasis Adapter, andAlliance Catheter Delivery SystemSt. Jude Medical, Daig Division |
| Device Description: | The Apeel™ CS Catheter Delivery System includes aPeelable Introducer Sheath, Dilator, Cannulator,Detachable Hemostasis Valve with Side Port,Guidewire, Syringe and Needle. The introducer kits areprovided sterile, and are intended for single-use only. |
| Intended Use: | The Apeel CS Catheter Delivery System is intendedto provide vascular access including the coronarysinus and serve as a conduit for the delivery andsupport of other devices where minimizing bloodloss 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.
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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) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 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).