(18 days)
The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices.
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 text describes a 510(k) premarket notification for an "Intracardiac Introducing Sheath and Accessories." This is a medical device, and the submission aims to demonstrate its substantial equivalence to previously marketed predicate devices, not an AI/ML powered device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding acceptance criteria and the study performed based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatibility testing on manufactured sheaths and dilators. | Qualified as equivalent; no new safety or effectiveness issues. |
| Sterilization | Sterilization validation of packaged units per ISO 11135 guidelines. | Qualified as equivalent; no new safety or effectiveness issues. |
| Reliability | Reliability testing such as shipping and accelerated aging of packaged units. | Qualified as equivalent; no new safety or effectiveness issues. |
| Mechanical Integrity | Tensile testing of the critical bond joints. | Qualified as equivalent; no new safety or effectiveness issues. |
| Functional Integrity | Rotational testing on the sheath to luer bond. | Qualified as equivalent; no new safety or effectiveness issues. |
| In Vitro Performance | Leak, friction forces, and insertions tests of the subject device in an in vitro setup. This testing aimed to qualify the equivalence between the subject device and the predicate devices for the intracardiac deployment of devices. | The results "indicate that the intracardiac introducing sheath and accessories perform as well as the predicate devices. Any differences in testing outcome are not significant." |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is an in vitro testing program designed to demonstrate the "substantial equivalence" of the subject device (Intracardiac Introducing Sheath and Accessories) to its predicate devices. The study involved a series of controlled laboratory tests measuring various physical, mechanical, and functional properties.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes used for each in vitro test. It generally refers to "manufactured sheaths and dilators" and "packaged units." For in vitro testing, this typically involves a representative number of devices to achieve statistical significance for the specific tests performed, but the exact count is not provided.
- Data Provenance: The data provenance is from laboratory testing (in vitro) conducted by Boston Scientific Corporation/EP Technologies. There is no mention of country of origin for the data (as it's in vitro testing, often performed internally or by contract labs), nor is it retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts & Qualifications: Not applicable. For this type of in vitro device performance testing, "ground truth" is typically established by predefined engineering specifications, industry standards (e.g., ISO 11135 for sterilization), and comparison to the performance of predicate devices, rather than expert clinical consensus. The testing engineers and quality control personnel are the "experts" in this context, ensuring adherence to protocols and specifications.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable in the clinical sense. In vitro testing results are compared against predetermined acceptance criteria (e.g., a tensile strength minimum, a leak rate maximum, visual inspection criteria, or direct comparison to predicate device performance). Any discrepancies would be handled by internal quality control and engineering review processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers interpret medical images. This submission is for a physical medical device (an introducer sheath).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used:
- Ground Truth Type: The "ground truth" or reference standard for this device's performance relies on:
- Engineering Specifications: Predefined performance metrics (e.g., bond strength, leak rates, friction forces).
- Industry Standards: Compliance with relevant international standards (e.g., ISO 11135 for sterilization).
- Predicate Device Performance: Direct comparison of the subject device's performance to that of the legally marketed predicate devices, demonstrating similar safety and effectiveness.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML algorithm that requires a training set. The device itself is manufactured to specifications.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable.
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510(k) Summary [as required by 21 CFR 807.87(h)]
| Date Prepared: | December 15, 1999 |
|---|---|
| Sponsor: | Boston Scientific Corporation2710 Orchard ParkwaySan Jose, CA 95134 |
| Telephone: | (408) 895-3625 |
| Contact: | Andrea Boumis |
| Title: | Regulatory Affairs Associate |
| Trade Name: | n/a |
| Common Name: | Intracardiac Introducing Sheath and Accessories |
| Classification Name: | Catheter, Introducer |
| Classification: | Class II-21 CFR 870.1340 |
| Predicate Devices: | Intracardiac Sheath |
| Device Description: | The intracardiac introducing sheath and accessories consists of: (1) adisposable introducer sheath, (2) a vessel dilator and (3) guidewire. |
| The intracardiac introducing sheath consists of a braided shaft, a softdistal tip, and marker band. The sheath comes with either a Hemostasisvalve or a luer fitting. The introducer sheaths are constructed in a rangeof curve reach configurations, diameters and lengths to respond tophysician preferences. The introducer sheath configurations coveredunder the subject 510(k) Premarket Notification include 8.5F and 9.5Fdiameter, angles ranging form 0° - 180 | |
| Intended Use: | The Boston Scientific/EP Technologies intracardiac introducing sheathsand accessories are designed to facilitate the intracardiac placement ofinterventional devices. |
| Technical Features: | The intracardiac introducer sheath combines design features ofmarketed predicate devices. The design features of the subject devicefall within ranges specified by the predicate devices. All the devices areopen lumen through which other medical devices can be passed.Further, all predicate devices allow for sideports through which air canbe aspirated, fluids can be infused, blood can be sampled, etc. |
| Performance Data: | In vitro testing qualified the equivalence between the subject device andthe predicate devices for the intracardiac deployment of devices andverified that no new safety or effectiveness issues. The type of testingis summarized below: |
| 1. Biocompatibility testing on manufactured sheaths and dilators;2. Sterilization validation of packaged units per ISO 11135 guidelines; |
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Reliability testing such as shipping, 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;
The results of the performance tests indicate that the intracardiac Conclusions: 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.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 4 2000
Ms. Andrea Boumis Requlatory Affairs Associate Boston Scientific Corporation 2710 Orchard Parkway San Jose. CA 95134
Re: K994252 Trade Name: Soft Tip Sheath Intracardiac Introducer with Accessories Requlatory Class: II Product Code: DYB December 13, 1999 Dated: Received: December 17, 1999
Dear Ms. Boumis:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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
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Page 2 - Dr. Petermann
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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
§ 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).