(45 days)
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use.
The BE 409 Pilot Tube Repair Kit will quickly and effectively restore the integrity of a pilot tube line when the regular pilot tube is accidentally cut or when the inflation port is cracked and does not maintain cuff pressure. This assembly will help prevent the need for costly and potentially dangerous tube replacement. The pilot tube connector will fit the pilot line of tubes 0.032 inch Inside Diameter - 0.050 inch Inside Diameter.
The BE 409 consists of a swaged needle with molded tab, a length of micro-bore tubing and a catheter with Luer-Lock fitting. A 10cc/mL syringe is now included in the package.
The provided text describes a Special 510(k) submission for the BE 409 Pilot Tube Repair Kit, primarily concerning the addition of a 10cc syringe and an updated instruction sheet. This submission does not contain information about a study proving device performance against acceptance criteria in the way one would typically expect for a new diagnostic or AI-driven device.
Here's an analysis based on the provided text, highlighting what's missing in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for cuff inflation pressure restoration, repair success rates, or durability). The purpose of this 510(k) is an addition to an already approved device, not a new device requiring extensive performance validation from scratch. The implied acceptance criterion is that the device, with the added syringe, continues to effectively restore the integrity of a pilot tube line and maintain cuff inflation pressure.
- Reported Device Performance: The document merely states "Performance: Use of a BE 409 Pilot Tube Repair Kit assists a health professional in safely repairing an endotracheal or tracheostomy tube that no longer maintains cuff inflation pressure due to a leaky pilot line, thus reducing the need to re-intubate the patient." This is a descriptive statement of its function and intended benefit, not a report of quantitative performance data from a study.
2. Sample Size Used for the Test Set and Data Provenance:
- No test set or study is described. Therefore, information on sample size and data provenance is absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Since no performance study is described, there's no mention of experts establishing ground truth.
4. Adjudication Method:
- Not applicable. No study or ground truth establishment process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No such study was done. This device is a mechanical repair kit, not an AI-driven medical imaging or diagnostic tool where MRMC studies would be relevant.
6. Standalone Performance Study:
- No standalone performance study is explicitly described. The 510(k) focuses on the mechanical function of the repair kit and the addition of a syringe. The underlying performance of the repair mechanism was presumably established during the original K973755 approval in December 1997. The current submission relies on the established function of the device.
7. Type of Ground Truth Used:
- Not applicable. No performance study to establish ground truth is mentioned in this document. The "ground truth" for this device's function would likely be its ability to physically seal a pilot tube and allow cuff inflation, which would have been validated through mechanical testing or benchtop studies during the original device approval.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI or machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is a mechanical device.
Summary of Device and 510(k) Focus:
The BE 409 Pilot Tube Repair Kit is a non-AI medical device used to repair pilot tubes of endotracheal or tracheostomy tubes. The K113644 510(k) submission is a "Special 510(k)" primarily for two modifications:
- Adding a 10cc syringe to the kit.
- Updating the User Instruction sheet.
Given the nature of these changes, the FDA's review would focus on ensuring these modifications do not negatively impact the safety or effectiveness of the already cleared device. The submission explicitly states, "No changes are being made to the device, thus no Predicate Device is listed in this summary," further indicating that the core functionality of the repair kit itself is not being re-evaluated for performance. The "performance" section describes the intended function and benefit rather than presenting new study data on its effectiveness.
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JAN 2 6 2012
Section 5 - 510(k) Summary Special 510 (k) Submission Page 1 of 2
Image /page/0/Picture/3 description: The image shows the logo for Instrumentation Industries, Inc. The logo includes a stylized graphic to the left of the company name. Below the company name is the tagline "We make Respiratory Care Work!"
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2990 Industrial Boulevard . Bethel Park, PA 15102-2536 Phone: 412-854-1133 US Toll-Free: 1-800-633-8577 Fax: 412-854-5668 www.iiimedical.com
Date Prepared: 12/9/2011 Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
SPECIAL 510(k) SUMMARY for the BE 409 Pilot Tube Repair Kit
| Trade Name | BE 409 Pilot Tube Repair Kit |
|---|---|
| CommonName | Pilot Tube Repair Kit |
| ClassificationName | Inflatable Tracheal Tube Cuff, Accessory to |
| Regulation | 21 CFR 868.5750 |
| Purpose of510(k)submission | The BE 409 Pilot Tube Repair Kit is used to repair an endotracheal ortracheostomy pilot tube that no longer maintains cuff inflation pressure. Tomake the repair, the leaking pilot tube is cut and the needle of the BE 409 isinserted into the cut end of the pilot tube. A syringe is then attached to theinflation port of the BE 409 and the cuff is re-inflated.The BE 409 Pilot Tube Repair Kit, (K973755), has been sold into commercesince its approval in December, 1997, but it never included the syringe that isneeded to complete the re-inflation of a repaired cuff. InstrumentationIndustries, Inc. wishes to correct this oversight and requests permission to addone 10cc syringe (without needle) to each assembled BE 409 Pilot TubeRepair Kit.Additionally we request permission to change the User Instruction sheet forthe BE 409 to update our company information as well as to make some minorchanges within the User information. |
| PredicateDevice | No changes are being made to the device, thus no Predicate Device is listed inthis summary. |
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Section 5 – 510(k) Summary
Special 510 (k) Submission Page 2 of 2 .
| Device Description | The BE 409 Pilot Tube Repair Kit will quickly and effectively restore the integrity of a pilot tube line when the regular pilot tube is accidentally cut or when the inflation port is cracked and does not maintain cuff pressure. This assembly will help prevent the need for costly and potentially dangerous tube replacement. The pilot tube connector will fit the pilot line of tubes 0.032 inch Inside Diameter - 0.050 inch Inside Diameter. |
|---|---|
| Intended Use of the Device | When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.This device is intended for sale by or on the order of a physician.The BE 409 Pilot Tube Repair Kit is intended for single patient use. |
| Technological Characteristics | The BE 409 consists of a swaged needle with molded tab, a length of micro-bore tubing and a catheter with Luer-Lock fitting. A 10cc/mL syringe is now included in the package. |
| Performance | Use of a BE 409 Pilot Tube Repair Kit assists a health professional in safely repairing an endotracheal or tracheostomy tube that no longer maintains cuff inflation pressure due to a leaky pilot line, thus reducing the need to re-intubate the patient. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and a single snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Doris F. Walter Regulatory Affairs. Ouality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Park Bethel Park, Pennsylvania 15102
JAN 2 6 2012
Re: K113644
Trade/Device Name: BE 409 Pilot Tube Repair Kit Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: II Product Code: BSK Dated: January 5, 2012 Received: January 6, 2012
Dear Ms. Walter:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Walter
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Q. for Anny D. Watson:
Anthony D. Watson, B.S., M.S., M.B.A. 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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Section 4 - Indications for Use Special 510(k) Submission Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name:
BE 409 Pilot Tube Repair Kit
Statement of Indications for Use:
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use.
Prescription Use ﮯ (Part 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)
Z. Schutk
(Division Sign-Off) ·Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).