(226 days)
The proposed Boston Scientific power injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
The proposed PICC is designed for intravenous therapy and for use with power injectors at settings of 300 psi for the administration of contrast media for imaging studies (including, but not limited to, CT scans, MRIs). The proposed PICC is an open ended, non-valved catheter with proximally located luer lock hub(s), extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL); with a reverse tapered shaft to aid in staunching bleeding at the insertion site; and usable length of 45 cm lengths for the 4 Fr SL, 5 Fr DL lengths and 55 cm lengths for the 4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL. The radiopaque catheter is marked with depth indicators every 1 cm along its length and with a "0" indicator to serve as a reference during catheter insertion and for user convenience in catheter sizing. The lumens are differentiated by proximally located colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s). As is the predicate device, the proposed BSC PICC will be offered in convenience kits with other legally marketed products.
This document, K070002, is a 510(k) summary for the Boston Scientific Peripherally Inserted Central Catheter (PICC). It focuses on substantial equivalence to a predicate device, rather than a standalone performance study with acceptance criteria.
Therefore, it does not contain the information required to populate the fields related to acceptance criteria and device performance as it pertains to AI/algorithm performance. The device described in this document is a physical medical device (PICC), not an AI algorithm.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. This document demonstrates substantial equivalence through a comparison of technological characteristics and performance characteristics tested to a predicate device, not by defining and meeting specific acceptance criteria for a new, AI-based functionality.
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm with a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth establishment is irrelevant for this type of device submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information from the document:
- Device Name: Boston Scientific Peripherally Inserted Central Catheter (PICC)
- Predicate Device: AngioDynamics, Inc. Morpheus™ CT PICC (K041420 and K060887)
- Intended Use: Short or long-term peripheral access to the central venous system for intravenous therapy (fluids, medications, nutrients, blood sampling) and power injection of contrast media.
- Substantial Equivalence Basis: Comparison of intended use, technological characteristics, and performance characteristics tested to the predicate device. The document states a "direct comparison of key characteristics demonstrates that the proposed device is substantially equivalent." However, the specific results of these characteristic tests or the defined criteria for "substantial equivalence" regarding measured performance are not detailed in this summary.
To obtain specific performance data and acceptance criteria for a physical device like a PICC, one would typically need to review the full 510(k) submission, which would include detailed testing protocols and results (e.g., burst pressure, flow rates, material compatibility, functional durability). This summary document does not provide those specifics.
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Ko70002
510(k) Summary for the Boston Scientific PICC
A. Sponsor
Boston Scientific/ Oncology Division 100 Boston Scientific Way Marlborough, MA 01756
AUG 17 2007
B. Contact
Nicholas Condakes Manager, Regulatory Affairs 508-683-4003 Or Lorraine M. Hanley Director, Global Regulatory Affairs 508-683-4173
C. Device Name
| Tradename: | To be determined |
|---|---|
| Common/usual name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Long term intravascular catheter21 CFR 880 5970 Class II |
D. Predicate Device(s)
| Tradename: | Morpheus™ CT PICC |
|---|---|
| Common/usual name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS- Long term intravascular catheter21 CFR 880.5970, Class II |
| Premarket Notification: | AngioDynamics, Inc. Morpheus™ CT PICC, K041420 and K060887 |
E. Device Description
The proposed PICC is designed for intravenous therapy and for use with power injectors at settings of 300 psi for the administration of contrast media for imaging studies (including, but not limited to, CT scans, MRIs). The proposed PICC is an open ended, non-valved catheter with proximally located luer lock hub(s), extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL); with a reverse tapered shaft to aid in staunching bleeding at the insertion site; and usable length of 45 cm lengths for the 4 Fr SL, 5 Fr DL lengths and 55 cm lengths for the 4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL. The radiopaque catheter is marked with depth indicators every 1 cm along its length and with a "0" indicator to serve as a reference during catheter insertion and for user convenience in catheter sizing. The lumens are differentiated by proximally located colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s). As is the predicate device, the proposed BSC PICC will be offered in convenience kits with other legally marketed products.
F. Intended Use
The proposed device is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
G. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA staff Format for Traditional and Abbreviated 510(k)s a direct comparison of key characteristics demonstrates that the proposed device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics tested.
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2007
Mr. Nicholas Condakes Manager, Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K070002
Trade/Device Name: Boston Scientific Peripherally Inserted Central Catheter Regulation Number: 21 CFR 880.5970 Regulation Name; Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 26, 2007 Received: July 272007
Dear Mr. Condakes:
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.
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Page 2 - Mr. Condakes
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 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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if Known):
X070002
Device Name: Undetermined
Indications For Use:
The proposed Boston Scientific power injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C
(Division Sign-Uff) Oivision of Anesthesiology, General Hospital nfection Control, Dental Devices
! 0(k) Number: 074002
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”