(24 days)
The Diagnostic Catheter System is intended for use as a sampling device by performing mini-bronchoalveolar lavage in adult patients undergoing mechanical ventilation in order to obtain lower respiratory tract samples for laboratory testing and diagnosis.
The Diagnostic Catheter System is a device that consists of an improved nonbronchoscopic Bronchoalveolar Lavage (BAL) catheter to be used for the blind retrieval of lower respiratory tract secretions (also know as mini-BAL).
The provided document is a 510(k) summary for the Cardinal Health Diagnostic Catheter System. It describes the device's intended use and the summary of technological characteristics compared to predicate devices. However, this document does not contain information on acceptance criteria for device performance, nor does it detail a study that proves the device meets specific performance criteria.
The document states:
- "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed devices with regard to functional characteristics."
- "All materials used in the fabrication of the Diagnostic Catheter System were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use."
This indicates that testing was performed to demonstrate substantial equivalence and material safety, but it does not provide:
- A table of explicit acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
- Reported device performance metrics against such criteria.
- Details of a clinical or analytical study proving the device meets performance criteria beyond substantial equivalence to predicate devices.
- Sample sizes for test sets or training sets.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth_ used (expert consensus, pathology, outcomes data).
- How ground truth for training data was established.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through extensive clinical trials as might be required for a PMA (Premarket Approval). The information provided is typical for a 510(k) submission, confirming design similarity, material compatibility, and functional equivalence but not specific performance metrics or detailed study results relevant to the requested questions.
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1091250
MAY 22 2009
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ventilator Acquired Pneumonia
Sponsor:
dinalHealth
Cardinal Health 1430 Waukegan Road MPKB-3B McGaw Park, IL 60085
Diagnostic Catheter System
Class II per 21CFR §874.4680
Requlatory Affairs: Contact
Telephone:
Date Summary Prepared:
March 2009
Sharon Nichols
(847) 578-6610
Common Name:
Classification Name:
Classification:
Predicate Devices:
Primary - Combicath, K974642, Plastimed Secondary - Balcath, K923487, Balllard
Bronchoscope, flexible or rigid and accessories
Description:
The Diagnostic Catheter System is a device that consists of an improved nonbronchoscopic Bronchoalveolar Lavage (BAL) catheter to be used for the blind retrieval of lower respiratory tract secretions (also know as mini-BAL).
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Intended Use:
The Diagnostic Catheter System is intended for use as a sampling device by performing mini-bronchoalveolar lavage in adult patients undergoing mechanical ventilation in order to obtain lower respiratory tract samples for laboratory testing and diagnosis.
Summary of Technological Characteristics:
The proposed device and the predicate device are composed of the same or similar design, materials and the manufacturing characteristics. Summary of testing: All materials used in the fabrication of the Diagnostic Catheter System were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Non-Clinical Testing:
Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed devices with regard to functional characteristics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES®
Public Health Service
MAY 22 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardinal Health, Inc. c/o Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062 Attn: Ned Devine
Re: K091250
Trade/Device Name: Diagnostic Catheter System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOQ Dated: May 14, 2009 Received: May 19, 2009
Dear Mr. Devine:
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 iddictions 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 Amendmouts 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 additional controls. Existing major regulations affecting your device (an he 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); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
Malvina B. Eglehm, m.s.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K69/250
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Image /page/4/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of three curved lines above the text "CardinalHealth". The lines are arranged in a way that they appear to be converging towards the right side of the image. The text is in a bold, sans-serif font.
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
Indication for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Unknown at this time
Diagnostic Catheter System
The Diagnostic Catheter System is intended for use as a sampling device by performing minibronchoalveolar lavage in adult patients undergoing mechanical ventilation in order to obtain lower respiratory tract samples for laboratory testing and diagnosis.
Prescription Use X (Per 21 CFR 801.109)
Over-The Counter Use Or
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Emile Th., MD
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K091250
000035
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§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.