(57 days)
Not Found
No
The description focuses on a simple pressure sensor and programmable thresholds, with no mention of learning, adaptation, or complex pattern recognition typically associated with AI/ML.
No
The device is described as an assessment tool to quantify fingertip pressure for tactile response procedures, not to treat a condition or disease.
No
The device is described as standardizing pain response by quantifying fingertip pressure during tactile examination, which is a measurement tool to assist an examiner, not to diagnose a condition itself.
No
The device description explicitly states it consists of a "thin sensor" that changes electrical resistance based on pressure, indicating a hardware component is integral to its function.
Based on the provided information, the Sonic Palpometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Sonic Palpometer Function: The Sonic Palpometer directly interacts with the patient's body (fingertip pressure on soft tissue) to assess sensitivity to tactile stimulus. It does not analyze samples taken from the body.
The device is a tool for physical examination and assessment, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and treatments that use digital palpation.
Product codes (comma separated list FDA assigned to the subject device)
IKE
Device Description
The Palpometer is a simple device that combines the fine motor and sensory attributes of manual examination with the precision measurements made with pressure gauges. By measuring the amount of pressure between the device and a soft tissue, the Palpometer standardizes pain response by controlling the pressure of the examiner's palpating finger. The Palpometer consists of a thin sensor, positioned on the palpating portion of the examiner's finger. The sensor changes its electrical resistance caused by varying the pressure exercised by the examining finger. The Palpometer beeps in a different tone as you pass through each programmable pressure threshold (of which there are five).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Manual palpation: Atkins, C. J. et al. (1992). An electronic method for measuring joint tenderness in rheumatoid arthritis. Arthritis & Rheum, 35:407-10. Results: P. 409. Analysis of the modified electronic scores showed an intraobserver error of 0.12 compared with 0.2 for the conventional method. The correlation coefficient between the Palpometer and conventional measurements was increased from 0.62 to 0.78 when the less sensitive instrument was excluded, indicating a high level of construct validity.
Tender point scores in headache: Bendtsen, L., Jensen, R., Jensen, N.K. and Olesen, J.R. (1995) Pressure controlled palpation: A new technique which increases the reliability of manual palpation. Cephalalgia 15, 205-210. Results: P. 206. The sum of tenderness scores recorded by two different observers using conventional palpation differed significantly (P=0.0003) where results did not differ using pressure controlled palpation (P=0.89). A positive linear correlation between pressure and pain intensity was found (P=0.00006).
Tender point scores in fibromyalgia: Bennet, R., Atkins, C.J., Zielinski, A., and Makosinski, A. (1996) A miniaturized pain-measuring device called an electronic Palpometer worn on the examiner's finger links a pressure gauge to conventional manual palpation. Collaborative study between University of Victoria with the Oregon Health Sciences University. Abstract in Proceedings of the 8th International Congress on Pain, August 1996, Vancouver, BC. Results: There was a good correlation (point estimates >0.7) between the Palpometer and conventional scores. Test retest measurements showed a similar correlation (>0.7).
Visual analog scale in fibromyalgia: Bendsten, L., Norregaard, J., Jensen, R., Olesen, J. (1997) Evidence of qualitatively altered nociception in patients with fibromyalgia. Arthritis & Rheum, 40:98. Results: P. 99. In controls there is a linear relationship between pressure and pain in a double logarithmic plot in which the slope (ß) was 3.5 ± 0.66 log mm/log Uj P
§ 890.1615 Miniature pressure transducer.
(a)
Identification. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
0
Image /page/0/Picture/1 description: The image is a logo for Palpometer Systems Inc. The logo features a stylized representation of a palpometer, with a circular sensor head and a stem extending downwards. The company name, "PALPOMETER SYSTEMS INC," is arranged in an arc above the sensor head, following the curve of the circle.
MAR 16 2006
PALPOMETER SYSTEMS INC PO Box 3075 STN CSC R Hut McKenzie Avenue Victoria, BC, Canada V8W 3W2 Telephone: 250.472.4321 Fax: 250.472.4321 Email: info@palpometer.net
- Website: www.palpometer.net
510(k) Summary
- Submitted by: Palpometer Systems Inc PO Box 3075 STN CSC R Hut McKenzie Ave Victoria, BC V8W 3W2 Tel: (250) 721-6502 Fax: (250) 721-6497
Contact: Lindsay Roach
Summary Prepared on January 6th, 2006
Trade Name: Sonic Palpometer
Common Name: palpometer
Classification Name: Miniature pressure transducer (per 21 CFR 890.1615)
Although there is no legally marketed predicate device for the Palpometer (as stated in the 513(g) device classification letter, reference: C030037, See Appendix B) these are devices in the same product code to which we are claiming some level of equivalence:
| Device | Applicant | 510(k) | Decision
Date | Device website
information |
|--------------------------------------|------------------------------------------------|-------------------------------|------------------|----------------------------------------------------------------------------------------------------------------------|
| Pressore Monitor | Cleveland Medical
Devices, Inc. | K954670 | 10/30/1995 | http://www.clevemed.
com/products/rehab/
pm/index.html |
| micro-emed-system | novel electronics,
inc. | K902967 | 09/17/1990 | http://www.novel.de/p
df/flyer/eng/rls_eng.p
df
http://www.novel.de/p
df/flyer/eng/emed_en
g_ver2.pdf |
| Dynatron 2000 | Dynatronics Corp. | K880912 | 03/15/1988 | http://www.dynatronic
s.com/chronicpain/dy
natron/
http://www.mdall.ca/
"dynatron" |
| emed-f-system | novel gmbh | K871690 | 05/15/1987 | http://www.novel.de/p
df/flyer/eng/rls_eng.p
df |
| ZEUS MicroWrist
Surgical System * | Intuitive Surgical
Inc., Computer
Motion | Approved
Class 3
device | | http://www.intuitivesu
rgical.com |
1
Image /page/1/Picture/0 description: The image shows the number 406000 at the top. Below the number is the number 1 followed by a dash. The numbers are written in a handwritten style. The image is a simple black and white picture.
Image /page/1/Picture/1 description: The image shows the logo and contact information for Palpometer Systems Inc. The logo features the company name surrounding a circular design. The contact information includes a PO Box address, a street address, the city and postal code, telephone and fax numbers, an email address, and a website. The phone and fax numbers are 250.472.4321.
- The ZEUS MicroWrist Surgical System is not in the same Product Code as the Palpometer, however it uses the same Interlink FSR pressure sensor.
Description:
The Palpometer is a simple device that combines the fine motor and sensory attributes of manual examination with the precision measurements made with pressure gauges. By measuring the amount of pressure between the device and a soft tissue, the Palpometer standardizes pain response by controlling the pressure of the examiner's palpating finger. The Palpometer consists of a thin sensor, positioned on the palpating portion of the examiner's finger. The sensor changes its electrical resistance caused by varying the pressure exercised by the examining finger. The Palpometer beeps in a different tone as you pass through each programmable pressure threshold (of which there are five).
Intended Use:
The intended use of the Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and treatments that use digital palpation.
Technological Characteristics:
The technological characteristics of the Palpometer are equivalent to several different devices. Like the Pressore Monitor, the Palpometer is a battery operated device that measures the amount of pressure between the device and soft tissue. The Palpometer uses a commercially available pressure sensor that converts mechanical inputs to analog signals similar to the Micro-emedsystems by novel electronics Inc. This sensor is the same one that is used in sensitive devices such as electronic infusion pumps, robotic controlled surgical systems (the Zeus MicroWrist Surgical System) and radiotherapy equipment to measure applied pressure. A programmed microprocessor, resistors, capacitors, reed switch, and piezoelectric speaker make up the other components. The level of pressure is indicated by the speaker that beeps at different tones depending upon the amount of pressure applied. The components are sealed inside a solid aluminum casing. The Palpometer is held in place on the finger by a Velcro strap.
Substantial Equivalence Data:
As there is no legally marketed predicate device (513(g) C030037, See Appendix B) a summary of the data and conclusions drawn from comparing the Palpometer to conventional means of pain measurement is included in the attached table.
2
| STANDARD MEASUREMENTS OF PAIN
COMPARED WITH THE SONIC
| PALPOMETER | SOURCE OF DATA | Results |
|---|---|---|
| Manual palpation | ||
| Tender joint scores in | ||
| rheumatoid arthritis | Atkins, C. J. et al. (1992). An electronic method for | |
| measuring joint tenderness in rheumatoid arthritis. | ||
| Arthritis & Rheum, 35:407-10 | P. 409. Analysis of the modified electronic scores showed an | |
| intraobserver error of 0.12 compared with 0.2 for the | ||
| conventional method. The correlation coefficient between the | ||
| Palpometer and conventional measurements was increased | ||
| from 0.62 to 0.78 when the less sensitive instrument was | ||
| excluded, indicating a high level of construct validity. | ||
| Tender point scores in | ||
| headache | Bendtsen, L., Jensen, R., Jensen, N.K. and Olesen, J.R. | |
| (1995) Pressure controlled palpation: A new technique | ||
| which increases the reliability of manual palpation. | ||
| Cephalalgia 15, 205-210 | P. 206. The sum of tenderness scores recorded by two different | |
| observers using conventional palpation differed significantly | ||
| (P=0.0003) where results did not differ using pressure controlled | ||
| palpation (P=0.89). A positive linear correlation between | ||
| pressure and pain intensity was found (P=0.00006). | ||
| Tender point scores in | ||
| fibromyalgia | Bennet, R., Atkins, C.J., Zielinski, A., and Makosinski, A. | |
| (1996) A miniaturized pain-measuring device called an | ||
| electronic Palpometer worn on the examiner's finger links | ||
| a pressure gauge to conventional manual palpation. | ||
| Collaborative study between University of Victoria with | ||
| the Oregon Health Sciences University. Abstract in | ||
| Proceedings of the 8th International Congress on Pain, | ||
| August 1996, Vancouver, BC. | There was a good correlation (point estimates >0.7) between the | |
| Palpometer and conventional scores. Test retest measurements | ||
| showed a similar correlation (>0.7). | ||
| Visual analog scale in fibromyalgia | Bendsten, L., Norregaard, J., Jensen, R., Olesen, J. | |
| (1997) Evidence of qualitatively altered nociception in | ||
| patients with fibromyalgia. Arthritis & Rheum, 40:98 | P. 99. In controls there is a linear relationship between pressure | |
| and pain in a double logarithmic plot in which the slope (ß) was | ||
| 3.5 ± 0.66 log mm/log Uj P |