SANDHILL SCIENTIFIC PEDIATEC PH PROBE

K013951 · Sandhill Scientific, Inc. · FFT · Feb 28, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013951
• Device Name: SANDHILL SCIENTIFIC PEDIATEC PH PROBE
• Applicant: Sandhill Scientific, Inc.
• Product Code: FFT · Gastroenterology, Urology
• Decision Date: Feb 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1400
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients

Device Story

The Sandhill Scientific PediaTec™ pH Probe is a stomach pH electrode designed for pediatric use. It functions by measuring hydrogen ion concentration (pH) within the esophagus and stomach. The device is intended for prescription use by healthcare professionals to monitor pH levels in pediatric patients. It serves as a diagnostic tool to assist clinicians in assessing gastric and esophageal acidity, which informs clinical decision-making regarding gastrointestinal health and potential acid-related conditions in children.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stomach pH electrode; Class I device; 21 CFR 876.1400; product code 78 FFT. No specific materials, dimensions, or software algorithms described.

Indications for Use

Indicated for measuring intragastric and intraesophageal pH in pediatric patients.

Regulatory Classification

Identification

A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

Predicate Devices

• Sandhill Disposable Internal Reference pH probe (K931963/A)

Submission Summary (Full Text)

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510(K) Summary K 013951 Page 1 of 2

FEB 2 8 2002

# GENERAL INFORMATION

### A. Trade Name

Sandhill Scientific PediaTec™ pH Probe

#### B. Common/Usual Name

Stomach pH Probe

#### C. Device Sponsor

Sandhill Scientific, Inc. 9150 Commerce Center Circle, #500 Highlands Ranch, CO 80129 303-470-7020 / 303-470-2975 fax

#### D. Establishment Registration

2023374

#### E. Classification

Class I 78 FFT 876.1400 Stomach pH Electrode, Exempt from 510(k)

#### F. Classification Panel

78. Gastroenterology and Urology Panel

#### G. This submission is being made for a modification to an existing approved 510(k) to add an indication for use with pediatric populations. See attached memo to Lewis Ward from Linda (Diederich), Vice President, Sandhill Scientific, Inc.

#### H. Substantial Equivalence

This pediatric pH probe is substantially equivalent to the Sandhill Disposable Internal Reference pH probe cleared under K931963/A, September 28, 1994.

#### I. Performance Standard

There is currently no performance standard for pH probes.

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" were ) Summary KO13951 Page 2012

7

## J. Official Contact

Lewis W. Ward, Consultant L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301

Telephone: [phone] Fax:

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2002

Sandhill Scientific, Inc. c/o Mr. Lewis W. Ward L. W. Ward and Associates, Inc. 4655 Kirkwood Court BOULDER CO 80301

Re: K013951

Trade/Device Name: Sandhill Scientific PediaTecTM Pediatric pH Probe Regulation Number: 21 CFR §876.1400 Regulation Name: Stomach pH electrode Regulatory Class: I Product Code: 78 FFT Dated: November 17, 2001 Received: November 30, 2001

Dear Mr. Ward:

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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21 CFR Part 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,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### KOB951 Initial 510(k): Sandhill Scientific, Inc.

Device Name: PediaTec ™, Pediatric pH Probe

Indications for Use:

Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-the-Counter Use | |
|----------------------|---|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |

Nancy/Cbrogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013951