(252 days)
No
The description focuses on signal acquisition, filtering, amplification, and digitization, with no mention of AI/ML algorithms for analysis or interpretation. The device acts as an accessory to a previously cleared system for display.
No.
The device is described as an "accessory signal acquisition device" that measures and displays physiological signals (pulse waveform, heart rate, myoelectrical signals from the stomach) for diagnostic aid. It does not provide any treatment or therapeutic intervention.
Yes
The Electrogastrography (EGG) Module is explicitly stated as an "aid to diagnosis of various gastric disorders," indicating its diagnostic purpose.
No
The device description explicitly states it is an "electronic accessory signal acquisition device" and details hardware components like signal conditioning circuits, LEDs, photoelectric sensors, and electrodes.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). The descriptions of the plethysmography and EGG modules clearly state they are measuring signals from the body non-invasively (plethysmography on the finger, EGG from electrodes on the body).
- The device is described as an "electronic accessory signal acquisition device." This indicates it's capturing physiological signals, not analyzing biological samples.
- The intended use and device description focus on measuring and displaying physiological signals. There is no mention of analyzing biological specimens.
Therefore, this device falls under the category of a medical device that measures physiological parameters, but it is not an IVD.
N/A
Intended Use / Indications for Use
Plethysmography Module: The device provides non-invasive measurement of pulse waveform and heart rate by photoelectric 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.
Product codes
FFZ, JOM, MYE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
The ACEM has been demonstrated electrically safe through testing and meeting IEC 60601-1 and IEC 60601-1-2 safety standards. The ACEM does not raise new issues of safety or effectiveness. Bench data confirms the plethysmograph and EGG channels meet the product specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KIII0 IS PIL
DEC 1 9 2011
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510(k) Summary
| Submitted by | Sandhill Scientific, Inc.
9150 Commerce Center Circle, #500
Highlands Ranch, CO 80129 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Lewis Ward
L.W. Ward and Associates, Inc.
4655 Kirkwood Court
Boulder, CO 80301
303-530-3279
lwward@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 JOM
System Electrogastrography (EGG), Product Code MYE |
| Intended Use | Plethysmography Module:
The device provides non-invasive measurement of pulse
waveform and heart rate by photoelectric
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. |
| Technological
Characteristics | 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. |
1
| Substantial Equivalence | The plethysmograph module is substantially equivalent to
the Meridian McPulse device K023238. The EGG
module is substantially equivalent to the 3CPM EGG
machine K984637. Function, technology, and signals are
equivalent. The ACEM is as safe and effective as the
legally marketed devices. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Data | The ACEM has been demonstrated electrically safe
through testing and meeting IEC 60601-1 and IEC 60601-
1-2 safety standards. The ACEM does not raise new
issues of safety or effectiveness. Bench data confirms the
plethysmograph and EGG channels meet the product
specifications. |
.
.
:
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2
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
3
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
4
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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