(23 days)
Boston Scientific/EP Technologies Convoy™ Advanced Delivery Sheaths and accessories are designed to facilitate the intracardial placement of interventional devices. The sheath may be exchanged and placed in interventional position after transseptal puncture has been obtained using a different sheath.
The Soft Tip Intracardiac Introducing Sheath Kit consist of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart.
The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.
The provided 510(k) summary (K013866) for the Convoy™ Advanced Delivery Sheath Kit does not contain information related to software, artificial intelligence, or machine learning. Therefore, it is not possible to describe acceptance criteria, device performance, or study details relevant to AI/ML devices based on this document.
The document discusses an "Intracardiac Introducing Sheath" and focuses on its physical characteristics, intended use, and comparison to a predicate physical device. The "Summary of the Non-clinical Data" section mentions "testing conformed to the requirements of 21 CFR Part 58" and "Non-clinical tests conducted for the Sheath (Good Laboratory Practices) demonstrated substantial equivalence to the predicate device." This indicates that the evaluation was likely based on bench testing of the physical sheath's properties (e.g., dimensions, materials, strength, sterile integrity) rather than performance related to data processing or algorithmic output.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device. The K013866 document pertains to a traditional medical device (a catheter introducer sheath).
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DEC 1 4 2001
Attachment 4 510(k) Summary
| Category: | Comments |
|---|---|
| Sponsor: | Boston Scientific Corporation2710 Orchard ParkwaySan Jose, CA 95134 |
| Correspondent: | Andrea L. RuthSenior Associate, Regulatory Affairs2710 Orchard ParkwaySan Jose, CA 95134 |
| Contact Information: | E-mail: rutha@bsci.comPhone: 408.895.3625Fax: 408.895.2202 |
| Device Common Name | Intracardiac Introducing Sheaths |
| Device Proprietary Name | Convoy™ Advanced Delivery Sheath Kit |
| Device Classification | Class II, DRF 21 CFR §870.1340 |
| Predicate Device | Intracardiac Introducing Sheaths |
| Predicate Device Manufacturer(s) | Boston Scientific Corporation |
| Predicate Device Proprietary Name(s) | Soft Tip Sheath Kit |
| Predicate Device Classification Number | Class II, DRF 21 CFR §870.1340 |
Date Summary Was Prepared:
November 20, 2001
Description of the Device:
The Soft Tip Intracardiac Introducing Sheath Kit consist of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart.
The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameter, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.
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Intended Use:
The Boston Scientific/EP Technologies Convoy Advanced Delivery The Doston Scientify as are designed to facilitate the intracardiac placement of interventional devices. The sheath may be exchanged placement of intervention ofter transseptal puncture has been obtained using a different sheath.
Comparison to Predicate Device:
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | K992309 | Current Submission |
| Intended Use | Intracardiac Placement ofInterventional Devices | Same |
| DeviceDescription | Intracardiac Introducing Sheath | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | BSC/EPT | Same |
| DeviceClassification | Class II, DRF; 21 CFR §870.1340 | Same |
Summary of the Non-clinical Data:
Where appropriate, testing conformed to the requirements of 21 CFR Part 58 Where appropriate, testing concess. Non-clinical tests conducted for the Sheath (Good Laboratory antial equivalence to the predicate device.
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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 & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs Boston Scientific Corporation c/o EP Technologies, Inc. 2710 Orchard Parkway San Jose, CA 95134
Re: K013866
Convoy Advanced Delivery Sheath Kit Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DBY Dated: November 20, 2001 Received: November 21, 2001
Dear Ms. Ruth:
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 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
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Page 2 - Ms. Andrea L. Ruth
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro reviews (2) consiste as described in your Section 510(k) This iciter will anow you to ough maing 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 and 11 you desire specific acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It is a 586. Additionally, for questions on the promotion and advertising of Compliance at (301) 597-1500. I final compliance at (301) 594-4639. Also, please note the your as to read to "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisoranany responsibilities under the Act may be obtained from the Oiner general 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 vours,
W. Odin Tall
am Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2 Intended Use Statement
K 013866 510(k) Number (if known):
Convoy™ Advanced Delivery Sheath Kit Device Name:
Indication for Use:
Boston Scientific/EP Technologies Convoy™ Advanced . The The boston Sheaths and accessories are designed to facilitate the Denvery "Sheadis" and "acceerventional devices. The sheath may be intracardial placement of interrental position after transseptal exchanged "and" a been obtained using a different sheath.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K015866
Prescription Use ✓
OR
Over-the-Counter Use_
(Per 21 CFR §801.109)
(Optional Format 1-2-96)
§ 866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.