(80 days)
Not Found
No
The summary describes a physical catheter for collecting samples and mentions no software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for specimen collection for diagnosis, not for treating a condition.
No
The device is a sampling catheter used to collect specimens for diagnosis, but it does not perform the diagnosis itself.
No
The device description clearly states it is a "catheter kit" and describes physical performance bench testing, indicating it is a physical medical device, not software-only.
Based on the provided information, the Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to collect a specimen (bronchoalveolar lavage) for diagnosis. It is a tool for specimen collection, not for performing the diagnostic test itself.
- Device Description: The description focuses on the catheter kit for performing the collection procedure.
- Lack of Diagnostic Function: The device itself does not perform any analysis or provide diagnostic information. The collected specimen would then be sent to a laboratory for in vitro diagnostic testing.
- No Mention of Diagnostic Assays or Reagents: IVD devices typically involve reagents, assays, or analytical components to perform a diagnostic test on a biological sample. This device is purely for sample collection.
Therefore, while the collected sample is used for in vitro diagnostic purposes, the catheter itself is a medical device used for specimen collection, not an IVD.
N/A
Intended Use / 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.
Product codes
OYI
Device Description
Sterile, single use, catheter kit for performing non-bronchoscopic Brochoalveolar Lavage (BAL) in adult patients undergoing mechanical ventilation. (also known as mini-BAL)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
adult intubated patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter has been tested for physical performance by bench testing demonstrating substantial equivalence to the predicate device and conformance to the applicable sections of the following standards: ISO 594-2:1998, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 11135-1:2007, and ISO 5356-1:2004.
All results of testing met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BAL Cath* (K923487)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 1 5 2011
K 112562 510(K) Summary November 22, 2011
| 510(k) Submitter: | 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 |
| ------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Primary Contact
for 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
. .
1
| Intended 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. |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics and
Substantial
Equivalence: | The performance testing of the Kimberly-Clark* KimVent* BAL
Cath* Bronchial Aspirate Sampling Catheter demonstrates that it
is 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 a
smaller catheter diameter. This difference in diameter raises no
new issues of safety and efficacy. |
| Summary of
Testing: | The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate
Sampling Catheter has been tested for physical performance by
bench testing demonstrating substantial equivalence to the
predicate device and conformance to the applicable sections of
the following standards: ISO 594-2:1998, ISO 10993-5:2009, ISO
10993-7:2008, ISO 10993-10:2010, ISO 11135-1:2007, and ISO
5356-1:2004.
All results of testing met acceptance criteria. |
*Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc.
2
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.
3
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
4
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
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