(90 days)
Used to measure intragastric and intraesophageal pH (hydrogen ion concentration) in pediatric patients
Not Found
Here's an analysis of the provided text regarding the Sandhill Scientific PediaTec™ pH Probe:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, no specific performance acceptance criteria or detailed device performance results are explicitly stated. The submission is for a modification to an existing approved 510(k) to add an indication for use with pediatric populations. It states that "There is currently no performance standard for pH probes."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a study proving the device meets acceptance criteria. The submission is primarily focused on demonstrating substantial equivalence to a previously cleared device (Sandhill Disposable Internal Reference pH probe cleared under K931963/A, September 28, 1994) for an expanded indication of use in pediatric populations.
3. Number of Experts Used to Establish Ground Truth and Qualifications
There is no mention of experts or the establishment of ground truth for a test set in the provided document.
4. Adjudication Method for the Test Set
No adjudication method is described, as there's no mention of a test set or associated study in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This device is a pH probe, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical pH probe, not an algorithm, so a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The document does not describe any specific ground truth for a study. For a pH probe, the "ground truth" would typically refer to the accuracy of its pH measurement against known standards. However, the document does not detail such testing for this submission.
8. Sample Size for the Training Set
No training set is mentioned as this is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Summary of the Study (or lack thereof) to Prove Acceptance Criteria:
The provided 510(k) summary (K013951) for the Sandhill Scientific PediaTec™ pH Probe is a regulatory submission for a modification to an existing device (Sandhill Disposable Internal Reference pH probe, K931963/A) to expand its indication to pediatric populations.
Crucially, the document does not describe a clinical study or specific performance testing against acceptance criteria to "prove the device meets acceptance criteria" in the way a new, high-risk device or an AI/software device often would. Instead, the basis for approval is "Substantial Equivalence" to a legally marketed predicate device (K931963/A). The FDA cleared the device based on the assessment that it is substantially equivalent to the predicate device for the stated indications for use, without requiring new performance standards or a detailed clinical study for the pediatric population. The document explicitly states, "There is currently no performance standard for pH probes."
Therefore, the "study" proving the device meets criteria is implicitly the demonstration of similarity to the predicate device, rather than a new, comprehensive performance study outlined in the provided 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
- 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: 303-530-3279 303-530-4774 Fax:
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Image /page/2/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 876.1400 Stomach pH electrode.
(a)
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.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.