(80 days)
The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is used in the diagnosis of diffuse lung disease by allowing collection of bronchoalveolar lavage (BAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.
Sterile, single use, catheter kit for performing non-bronchoscopic Brochoalveolar Lavage (BAL) in adult patients undergoing mechanical ventilation. (also known as mini-BAL)
The document provided is a 510(k) summary for a medical device called the "Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific performance criteria for AI/ML systems.
Therefore, much of the requested information (such as AI/ML specific metrics, expert adjudication, MRMC studies, training set details, etc.) is not applicable and cannot be extracted from this document, as the device is a physical catheter, not an AI/ML system.
However, I can provide the available information regarding the device's acceptance criteria and how it was proven to meet them, based on the provided text.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance
The device is a physical catheter, and its performance was evaluated through bench testing against established standards, not through specific clinical performance metrics like sensitivity or specificity typically associated with AI/ML systems.
| Acceptance Criteria Category | Reported Device Performance (Summary of Testing) |
|---|---|
| Physical Performance | Demonstrates substantial equivalence to the predicate device (BAL Cath* K923487). |
| Standard Conformance | Conforms to applicable sections of: - ISO 594-2:1998 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings) - ISO 10993-5:2009 (Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity) - ISO 10993-7:2008 (Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals) - ISO 10993-10:2010 (Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization) - ISO 11135-1:2007 (Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) - ISO 5356-1:2004 (Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets) |
| Overall Outcome | All results of testing met acceptance criteria. |
2. Sample size used for the test set and the data provenance
Not applicable for a physical device being evaluated through bench testing. The "test set" here refers to the samples or units of the physical device subjected to the bench tests. The document does not specify the number of units tested.
Data provenance (country of origin, retrospective/prospective) is also not applicable as this is not a study involving human data or AI/ML model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to validated classifications or outcomes. For a physical device's performance, the "ground truth" is typically defined by the objective measurements and pass/fail criteria specified by the benchmarking standards (e.g., specific force, flow rate, or biocompatibility limits). These are set by the standard-setting bodies, not by human experts adjudicating individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for physical device testing against technical standards.
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 a physical catheter, not an AI/ML system, and no human reader studies with or without AI assistance were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The "standalone performance" refers to the device's ability to meet the specified physical and material criteria through bench testing, as summarized in Section 1.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" for proving acceptance criteria was based on objective measurements and conformance to established international standards (ISO standards listed above) for physical properties, biocompatibility, and sterilization.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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DEC 1 5 2011
K 112562 510(K) Summary November 22, 2011
| 510(k) Submitter: | David M. Lee, J.D.Associate Director of Regulatory AffairsKimberly-Clark Health Care1400 Holcomb Bridge RoadRoswell, GA 30076Ph: 770.587.7167FAX: 920.225.4784Email: David.Lee@kcc.com |
|---|---|
| ------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Primary Contactfor this 510(k)Submission: | David M. Lee, J.D. |
|---|---|
| Associate Director of Regulatory Affairs | |
| Kimberly-Clark Health Care | |
| 1400 Holcomb Bridge Road | |
| Roswell, GA 30076 | |
| Ph: 770.587.7167 | |
| FAX: 920.225.4784 | |
| Email: David.Lee@kcc.com |
BAL Cath*
OYI, Class I
(21 CFR 868.6810)
Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Device Trade Catheter (Product Code 143) Name:
Device Common names
Date Summary was
Prepared:
Device Product Codes and Classification Names:
-
Predicate Devices The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is substantially equivalent to the predicate device, BAL Cath* (K923487).
Catheters, suction, tracheobronchial -
Sterile, single use, catheter kit for performing non-bronchoscopic Device Brochoalveolar Lavage (BAL) in adult patients undergoing Description: mechanical ventilation. (also known as mini-BAL)
1
. .
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| Intended Use: | The Kimberly-Clark* KimVent* BAL Cath* Bronchial AspirateSampling Catheter is used in the diagnosis of diffuse lung diseaseby allowing collection of bronchoalveolar lavage (BAL) specimensfrom deep within the lung. The use of a bronchoscope is notnecessary. This catheter is used in adult intubated patients. |
|---|---|
| TechnologicalCharacteristics andSubstantialEquivalence: | The performance testing of the Kimberly-Clark* KimVent* BALCath* Bronchial Aspirate Sampling Catheter demonstrates that itis substantially equivalent to the predicate device, BAL Cath*(K923487) in intended use, design, packaging, manufacturing,biocompatibility, and performance. The Kimberly-Clark* KimVent*BAL Cath* Bronchial Aspirate Sampling Catheter incorporates asmaller catheter diameter. This difference in diameter raises nonew issues of safety and efficacy. |
| Summary ofTesting: | The Kimberly-Clark* KimVent* BAL Cath* Bronchial AspirateSampling Catheter has been tested for physical performance bybench testing demonstrating substantial equivalence to thepredicate device and conformance to the applicable sections ofthe following standards: ISO 594-2:1998, ISO 10993-5:2009, ISO10993-7:2008, ISO 10993-10:2010, ISO 11135-1:2007, and ISO5356-1:2004.All results of testing met acceptance criteria. |
*Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David M. Lee, J.D. Associate Director of Regulatory Affairs Kimberly-Clark Healthcare 1400 Holcomb Bridge Road Roswell. Georgia 30076
DEC 1 5 2011
Re: K112562
Trade/Device Name: Kimberly-Clark* KimVent BAL Cath Bronchial Aspirate Sampling Catheter Regulation Number: 21 CFR 868.6810 Regulation Name: Tracheobronchial Suction Catheter Regulatory Class: 1 Product Code: OYI Dated: August 31, 2011 Received: September 26, 2011
Dear Mr. Lee:
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 - Mr. Lee
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 (OS) 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,
Anthony D. anovan
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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Kimberly-Clark" Corporation 510(k) for the Kimberly-Clark" KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter
Indications for Use:
The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is used in the diagnosis of diffuse lung disease by allowing collection of bronchoalveolar lavage (BAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.
Prescription Use ___ x (Part 21 CFR 801 Subpart D)
Over - The - Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
urrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K112562
5
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.