(252 days)
Plethysmography Module:
The device provides non-invasive measurement of pulse waveform and heart rate by photoclectric plethysmography.
Electrogastrography (EGG) Module:
A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.
The ACEM is an electronic accessory signal acquisition device. The ACEM includes five (5) signal conditioning circuits: respiration, plethysmograph, ECG and two channels of the EGG. Respiration and ECG have previous clearance under the InSight 510(k) K012232. The new plethysmograph accessory consists of a small, red LED placed against the finger and a photoelectric sensor to measure changes in the light intensity. The filter signal is amplified and digitized.
The added EGG signal conditioning unit receives signals from the body through standard pad electrodes. The signals are filtered and digitized.
Both the plethysmograph and EGG signals are forwarded to the Sandhill InSight System (K012232) for display.
The provided document is a 510(k) summary for the ACEM (Sensor Pac, signal acquisition) device. It describes the device's intended use and technological characteristics, as well as its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, ground truth establishment methods, or information about MRMC studies.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided document. The document primarily focuses on establishing substantial equivalence to predicate devices and electrical safety. It states:
- "Bench data confirms the plethysmograph and EGG channels meet the product specifications."
This implies that there were product specifications and that bench data was used to demonstrate adherence to them, but the specifications themselves and the exact performance results are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the document. No specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is described. The relevant section states:
- "Bench data confirms the plethysmograph and EGG channels meet the product specifications."
This suggests internal testing, but no details are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not present in the document. There is no mention of human experts or ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not present in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
This information is not present in the document. The document does not describe any studies involving human readers or comparative effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The device (ACEM) is a signal acquisition device that forwards signals to another system (Sandhill InSight System, K012232) for display. It is not an AI algorithm that produces an interpretation or diagnosis on its own. Therefore, the concept of "standalone performance" for an algorithm, as typically applied to AI, does not directly apply here. The "bench data" mentioned would likely be an assessment of the hardware's ability to accurately acquire and condition the physiological signals according to its specifications.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI models (e.g., pathology, outcomes data, expert concensus) is not applicable to this device in the context of the provided information. The ACEM is a signal acquisition device. Its "performance" would be related to the accuracy and reliability of signal capture and conditioning, likely verified against known physical inputs or established measurement standards, rather than a diagnostic "ground truth." The document states:
- "Bench data confirms the plethysmograph and EGG channels meet the product specifications."
This implies that the "ground truth" for this device's performance would be the expected electrical or physiological signals that the device is designed to measure, and its ability to accurately and reliably capture them.
8. The Sample Size for the Training Set
This information is not present in the document. As this device is a signal acquisition hardware and not an AI algorithm, a "training set" in the machine learning sense is not relevant.
9. How the Ground Truth for the Training Set was Established
This information is not present in the document, as it is not an AI algorithm, and therefore, a training set with established ground truth is not applicable in the context of this 510(k) summary.
Summary of Study Information Provided:
The document describes electrical safety testing and bench data testing to confirm product specifications.
- Acceptance Criteria (Implied): The device must meet IEC 60601-1 and IEC 60601-1-2 safety standards. The plethysmograph and EGG channels must meet their respective product specifications.
- Study Proving Acceptance Criteria:
- Electrical Safety Testing: The ACEM was demonstrated electrically safe through testing and meeting IEC 60601-1 and IEC 60601-1-2 safety standards.
- Performance Bench Testing: Bench data was used to confirm that the plethysmograph and EGG channels meet the product specifications.
- Sample Size for Test Set: Not specified, but likely refers to a series of controlled bench tests.
- Data Provenance: Implied to be internal bench testing.
- Experts for Ground Truth: Not applicable/not specified.
- Adjudication Method: Not applicable/not specified.
- MRMC Study: No.
- Standalone Performance (Algorithm): Not applicable, as it's a hardware signal acquisition device.
- Type of Ground Truth: For safety, adherence to international electrical safety standards. For performance, meeting "product specifications" through bench data, likely implying accuracy against known inputs.
- Training Set Sample Size: Not applicable.
- Training Set Ground Truth Establishment: Not applicable.
In essence, the 510(k) summary for the ACEM device is based on demonstrating substantial equivalence to predicate devices and verifying electrical safety and basic functional performance through bench testing, rather than a clinical trial or AI model validation study.
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KIII0 IS PIL
DEC 1 9 2011
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510(k) Summary
| Submitted by | Sandhill Scientific, Inc.9150 Commerce Center Circle, #500Highlands Ranch, CO 80129 |
|---|---|
| Contact Person | Lewis WardL.W. Ward and Associates, Inc.4655 Kirkwood CourtBoulder, CO 80301303-530-3279lwward@qwest.net |
| Date Prepared | 3-25-11 |
| Device Trade Name | ACEM |
| Common Name | Sensor Pac, signal acquisition |
| Regulation Number | 870.2780 Cardiovascular (plethysmograph)876.1735 Gastroenterology (electrogastrography) |
| Classification Name | Plethysmograph, Product Code JOMSystem Electrogastrography (EGG), Product Code MYE |
| Intended Use | Plethysmography Module:The device provides non-invasive measurement of pulsewaveform and heart rate by photoelectricplethysmography.Electrogastrography (EGG) Module:A device that receives, records, and produces a visualdisplay of the myoelectrical signal produced by thestomach as an aid to diagnosis of various gastricdisorders. |
| TechnologicalCharacteristics | The ACEM is an electronic accessory signal acquisitiondevice. The ACEM includes five (5) signal conditioningcircuits: respiration, plethysmograph, ECG and twochannels of the EGG. Respiration and ECG haveprevious clearance under the InSight 510(k) K012232.The new plethysmograph accessory consists of a small,red LED placed against the finger and a photoelectricsensor to measure changes in the light intensity. The filtersignal is amplified and digitized.The added EGG signal conditioning unit receives signalsfrom the body through standard pad electrodes. Thesignals are filtered and digitized.Both the plethysmograph and EGG signals are forwardedto the Sandhill InSight System (K012232) for display. |
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| Substantial Equivalence | The plethysmograph module is substantially equivalent tothe Meridian McPulse device K023238. The EGGmodule is substantially equivalent to the 3CPM EGGmachine K984637. Function, technology, and signals areequivalent. The ACEM is as safe and effective as thelegally marketed devices. |
|---|---|
| Test Data | The ACEM has been demonstrated electrically safethrough testing and meeting IEC 60601-1 and IEC 60601-1-2 safety standards. The ACEM does not raise newissues of safety or effectiveness. Bench data confirms theplethysmograph and EGG channels meet the productspecifications. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 9 2011
Sandhill Scientific, Inc. c/o Mr. Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301
K111013 Re:
Trade/Device Name: ACEM Sensor Pac Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: Class II (two) Product Codes: FFZ, JOM, MYE Dated: November 30, 2011 Received: December 7, 2011
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
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Page 2 - Mr. Lewis Ward
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutf-DA/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/ReportalProblem/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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): KIII013
Device Name: ACEM
Indications for Use:
Plethysmography Module:
The device provides non-invasive measurement of pulse waveform and heart rate by photoclectric plethysmography.
Electrogastrography (EGG) Module:
A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
F.C. for bdz
pvascular Devices
510(k) Number K111013
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.