(90 days)
The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained by another sheath.
The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft a soft distal tip and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. 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 8.5F and 9.5F diameter, angles ranging form 0° - 180
The provided document is a 510(k) summary for an "Intracardiac Introducing Sheath and Accessories." This type of submission focuses on demonstrating substantial equivalence to predicate devices for medical devices, rather than establishing efficacy through clinical trials with specific performance metrics akin to software device approval.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/software device does not apply to this document.
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., sensitivity, specificity). The acceptance criteria for this device revolve around demonstrating substantial equivalence to predicate devices in terms of design features, materials, and in vitro performance, ensuring no new safety or effectiveness issues.
- Reported Device Performance:
Test Type Reported Performance Biocompatibility testing Qualified the equivalence between the subject device and dilators. Sterilization validation Validated per ISO 11135 guidelines. Reliability testing Included shipping and accelerated aging of packaged units. Tensile testing Performed on critical bond joints. Rotational testing Performed on the sheath to luer bond. Leak, friction forces, insertion Performed in an in vitro setup, indicating performance as well as predicate devices for these aspects.
2. Sample sized used for the test set and the data provenance:
- This document describes in vitro testing, not a clinical study with human subjects or a dataset for AI. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not applicable. The tests were performed on manufactured units of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications:
- Not applicable. This is not a study requiring expert readers to establish ground truth. Device performance was assessed through engineering and laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication process is relevant for this type of in vitro testing.
5. 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 an intracardiac introducing sheath, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Ground truth" in this context refers to established engineering standards, material properties requirements, and performance specifications for medical devices. For example, sterilization validation adheres to ISO 11135 guidelines, and tensile strength tests have defined pass/fail criteria based on material science and predicate device performance. The in vitro tests verify that the device meets these engineering and safety standards.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of available information:
The document details a 510(k) submission for a physical medical device. The "performance data" provided consists of various in vitro engineering and biocompatibility tests designed to demonstrate that the new device is substantially equivalent to existing predicate devices and does not raise new safety or effectiveness concerns. It does not involve AI or clinical studies with human subjects in the way your questions are framed.
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E. 510(k) Summary [as required by 21 CFR 807.87(h)] Date Prepared: July 1, 1999 Sponsor: Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134 Telephone: (408) 895-3608 Contact: Susan Pool Title: Manager, Regulatory Affairs Trade Name: n/a Common Name: Intracardiac Introducing Sheath and Accessories Classification Name: Catheter, Introducer Classification: Class II-21 CFR 870.1310 Class II-21 CFR 870.1340 Predicate Devices: Percutaneous Introducer Set, Long Length Percutaneous Introducer Set; EPT Constellation Outer Guiding Catheters, Fast-Cath™ Intracardiac Introducer, Cook Toughy-Borst Introducer set * Device Description: The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft a soft distal tip and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. 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 8.5F and 9.5F diameter, angles ranging form 0° - 180 Intended Use: The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. Technical Features: The intracardiac introducer sheath combines design features of marketed predicate devices. The design features of the subject devices of fall within ranges specified by the predicate devices. All the devices are Further oll madicate which other medical devices can be passed. Further, all predicate devices allow for sideports through which air can be aspirated, fluids can be infused, blood can be sampled, etc. Performance Data: In vitro testing qualified the equivalence between the subject device and the predicate devices for the intracardiac deployment of devices and
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verified that no new safety or effectiveness issues. The type of testing is summarized below:
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Biocompatibility testing on manufactured sheaths and dilators;
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Sterilization validation of packaged units per ISO 11135 guidelines;
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Reliability testing such as shiping, and accelerated aging of packaged units:
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Tensile testing of the critical bond joints;
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Rotational testing on the sheath to luer bond;
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Leak, friction forces and insertions tests of the subject device in an in vitro setup;
Conclusions: The results of the performance tests indicate that the intracardiac introducing sheath and accessories perform as well as the predicate devices. Any differences in testing outcome are not significant. Therefore, Boston Scientific Corporation/ EP Technologies concludes that the intracardiac introducing sheath and accessories is substantially equivalent to the predicate devices, Percutaneous Introducer Set, Long Length Percutaneous Introducer Set; EPT Constellation Outer Guiding Catheters, Fast-Cath™ Intracardiac Introducer, Cook Toughy-Borst Introducer set. な
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three lines forming the body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 1999
Ms. Susan Pool Manager, Regulatory Affairs Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134
Re : K992309 Intracardiac Introducing Sheath and Accessories Trade Name: Regulatory Class: II Product Code: DYB July 8, 1999 Dated: Received: July 9, 1999
Dear Ms. Pool:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in
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Page 2 - Ms. Susan Pool
the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. O'Keefe
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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D. Indications For Use Statement
510(k) Number (if known):
Intracardiac Introducing Sheath and accessories Device Name: __
Indication For Use:
发
The Boston Scientific/EP Technologies sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained by another sheath.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
AntyMullAb
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K492309 510(k) Number
Prescription Use
.OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(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).