BACT/ALERT PF CULTURE BOTTLE

K020923 · bioMerieux, Inc. · MDB · Apr 18, 2002 · Microbiology

Device Facts

• Record ID: K020923
• Device Name: BACT/ALERT PF CULTURE BOTTLE
• Applicant: bioMerieux, Inc.
• Product Code: MDB · Microbiology
• Decision Date: Apr 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

BacT/ALERT® PF Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.

Device Story

BacT/ALERT PF Plastic Culture Bottle is a sterile container for blood culture; used with BacT/ALERT Microbial Detection Systems. Input: blood sample inoculated into bottle. Principle: bottle incubated in instrument; continuous monitoring via reflectance technology; sensor detects CO2 production resulting from microbial growth. Output: qualitative detection of microorganisms. Used in clinical laboratory settings by trained personnel. Healthcare providers use results to identify blood infections. Benefits: provides nutritional/environmental conditions for microbial recovery; plastic material offers alternative to glass.

Clinical Evidence

Bench testing only. Seeded studies performed on 23 organisms diluted in human blood. Compared BacT/ALERT PF Plastic Culture bottle to BacT/ALERT PF Glass Culture bottle. Results showed equivalent recovery of low levels of microorganisms and equivalent detection times.

Technological Characteristics

Plastic culture bottle; reflectance-based detection; CO2-sensitive sensor using Xylenol Blue in silicone emulsion. Compatible with existing BacT/ALERT Microbial Detection Systems. Qualitative microbial growth monitor.

Indications for Use

Indicated for pediatric patients for the qualitative recovery and detection of aerobic and facultative anaerobic bacteria and yeast from blood samples.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• BacT/Alert PF Glass Culture Bottle (K992401)

Submission Summary (Full Text)

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# APR 1 8 2002

K620923

### 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT PF (Plastic) Culture Bottle

# 510(k) Summary

#### The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;

Submitter's Name:

bioMérieux, Inc.

Submitter's Address:

100 Rodolphe Street, Durham, North Carolina 27712 [phone]

Submitter's Telephone:

Submitter's Contact:

Ron Sanyal Ron Sanyal

Date 510(k) Summary Prepared: March 20, 2002

- The name of the device, including the trade or proprietary name if applicable, the common (a)(2) or usual name, and the classification name, if known;
Trade or Proprietary Name: BacT/ALERT PF Culture Bottle

Common or Usual Name: BacT/ALERT PF Culture Bottle

Classification Name: Microbial Growth Monitor

- An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence:
Device Equivalent to: BacT/Alert PF Glass Culture Bottle

- A description of the device. (a)(4)
Device Description: The BacT/ALERT PF Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT PF Glass Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT PF Bottle.

- A statement of the intended use of the device. (a)(5)
Device Intended Use: BacT/ALERT® PF Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.

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## 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT PF (Plastic) Culture Bottle

### A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.

The BacT/ALERT PF Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT PF Glass Culture Bottle. The similarities and/or differences with marketed device are listed in Table (a) (6) 1.

| FEATURES | BACT/ALERT PF PLASTIC CULTURE<br>BOTTLE | BACT/ALERT PF GLASS<br>CULTURE BOTTLE |
|-----------------------------------------|-----------------------------------------|-------------------------------------------|
| | | (K992401) |
| Intended Use | Same | Same |
| Culture Bottle Material | Plastic | Glass |
| Product Code | MDB | MDB |
| Technology | Reflectance | Reflectance |
| Color change based on<br>CO2 production | YES | YES |
| Sensor | Emulsion | Emulsion |
| Indicator material | Xylenol Blue in Silicone Emulsion | Xylenol Blue in Silicone Emulsion |
| Growth of<br>microorganisms | Same | Same |
| Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial<br>Detection Systems |
| Sample Source | Blood | Blood |
| Target Population | Pediatric | Pediatric |

## TABLE (a)(6).1

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### 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT PF (Plastic) Culture Bottle

#### A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency.

Testing was performed to establish the performance characteristics of the new device including:

Seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT PF Plastic Culture bottle and the BacT/ALERT PF Glass Culture bottle.

### The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).

The BacT/ALERT PF Plastic Culture Bottle was substantially equivalent to the BacT/ALERT PF Glass Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times were equivalent in both bottles.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ron Sanyal, M. Pharm., CQE, RAC Manager, Regulatory Affairs Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712

APR 1 8 2002

k020923 Re:

Trade/Device Name: BacT/ALERT® PF Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: March 20, 2002 Received: March 21, 2002

Dear Mr. Sanyal:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); 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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Page 2 -

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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ની Page

510(k) Number (If known):

. BacT/ALERT PF Culture Bottle

Indications: For Usa:

Device Name:

The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial The Dact / All Collective procedures for enhanced recovery and detection of Delection Dystems in qualitative procedures (bacteria and yeast) from blood.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-The Counter Use

(Optional Format 1-2-98)

Freddie L. Lode

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K020923

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