(90 days)
QQO
The provided text states "Reference Device(s) Not Found". Therefore, no K/DEN numbers can be identified.
Yes
The device description mentions "segmentation of the head contour and nose tip," which is a common application of image processing techniques that often utilize AI/ML algorithms for accurate identification and delineation. While not explicitly stated as AI/ML, the nature of this task strongly suggests its use.
No
The device is intended for cranial measurement and is explicitly stated as "not intended to be used as a tool for preparing a helmet," indicating it is for diagnostic or measurement purposes rather than active treatment.
Yes
The device measures cranial index (CI) and cranial vault asymmetry index (CVAI) of infants' heads, which are quantitative measurements used in conjunction with other clinical methods. These measurements are similar to those taken by a mechanical caliper, a diagnostic tool, and are used to monitor head shape, which can indicate conditions like plagiocephaly or brachycephaly. The results are provided in a PDF report to a physician, who then discusses them with the parents and determines next steps, indicating its use in assessing a medical condition.
Yes
The device is explicitly described as "SoftSpot™ is a software that runs on a smartphone, tablet, PC, etc." and its function is solely based on processing images to calculate cranial measurements. While it utilizes hardware (smartphone, tablet, PC) for input and display, the device itself is the software performing the analysis.
Based on the provided information, the SoftSpot™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The core function of an IVD is to examine samples like blood, urine, tissue, etc., to provide information about a person's health.
- SoftSpot™ analyzes images of the infant's head. It uses external images to perform measurements, not biological specimens.
- The intended use is for cranial measurement. This is a physical measurement of the head shape, not a diagnostic test based on analyzing bodily fluids or tissues.
- The device description focuses on image processing and measurement calculation. It describes how the software processes images to determine cranial indices, which is distinct from the analytical processes involved in IVD testing.
While the results from SoftSpot™ are used in conjunction with other clinical methods to inform diagnosis and treatment decisions, the device itself does not perform an in vitro diagnostic test. It's a measurement tool based on external imaging.
No
The provided text states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating that the letter does not contain any information about a PCCP being reviewed, approved, or cleared for this device.
Intended Use / Indications for Use
SoftSpot™ is intended to be used for cranial measurement for infants from 1 month up to 2 years of age in conjunction with other clinical methods.
SoftSpot™ is not intended to be used as a tool for preparing a helmet.
Product codes
QQO
Device Description
SoftSpot™ is a software that runs on a smartphone, tablet, PC, etc. and uses top view pictures of infant's head to measure cranial index (CI) and cranial vault asymmetry index (CVAI) similar to a mechanical caliper used by physicians which is also known as craniometer.
After the photo is taken, the head contour is identified and then, based on the current standards of measuring infants' head shape, characterizing parameters including the ratio of width over length (known as Cranial Index or CI) and the ratio of difference in diagonals over the larger one (known as Cephalic Vault Asymmetry Index or CVAI) are calculated (see Test Principle below).
The SoftSpot platform allows different users to upload or capture top view videos and photos of the infant's head. The user can be a physician/nurse (during well visits) or parents/guardians (between the visits). Once data are collected, they are sent to PediaMetrix Amazon Web Services (AWS) cloud. At PediaMetrix, the data analyst will use a windows-based software to download and analyze the data. The analysis includes conversion of the video into photos, standardization of the images (3x4, all nose up), selection of 5 good images, segmentation of the head contour and nose tip. Then, the software will calculate Cl and CVAI. Finally, a pdf report is generated with the results and sample top view photos and sent to the physician's account. Parents will also be notified when the results are ready. Then, the parent visits the physician (either in person or online) to discuss the results and next steps.
Mentions image processing
After the photo is taken, the head contour is identified and then, based on the current standards of measuring infants' head shape, characterizing parameters including the ratio of width over length (known as Cranial Index or CI) and the ratio of difference in diagonals over the larger one (known as Cephalic Vault Asymmetry Index or CVAI) are calculated (see Test Principle below).
The SoftSpot platform allows different users to upload or capture top view videos and photos of the infant's head. The user can be a physician/nurse (during well visits) or parents/guaradians (between the visits). Once data are collected, they are sent to PediaMetrix Amazon Web Services (AWS) cloud. At PediaMetrix, the data analyst will use a windows-based software to download and analyze the data. The analysis includes conversion of the video into photos, standardization of the images (3x4, all nose up), selection of 5 good images, segmentation of the head contour and nose tip. Then, the software will calculate Cl and CVAI. Finally, a pdf report is generated with the results and sample top view photos and sent to the physician's account. Parents will also be notified when the results are ready. Then, the parent visits the physician (either in person or online) to discuss the results and next steps.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
top view pictures of infant's head
top view videos and photos of the infant's head.
Anatomical Site
cranial
Indicated Patient Age Range
infants from 1 month up to 2 years of age
Intended User / Care Setting
The user can be a physician/nurse (during well visits) or parents/guardians (between the visits).
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
Prospective Study:
- Sample Size: 25 infants
- Age Range: 3 to 12 months
- Data Source: Plagiocephaly clinic at the University of Pittsburgh Children Hospital
- Annotation Protocol: Not explicitly stated, but measurements were compared to those taken by clinicians using a standard caliper.
Retrospective Study:
- Sample Size: 100 infants' head measurements
- Age Range: 3-20 months
- Data Source: Helmet clinic at Singapore; 2D rendered images from 3D head scans (.stl format) of patients with cranial deformities (deformational plagiocephaly and brachycephaly (DPB)).
- Annotation Protocol: Not explicitly stated, but measurements were compared with direct measurements from 3D scans.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Prospective
- Study Type: Comparative study
- Sample Size: 25 infants (age range 3 to 12 months)
- Key Results: The Spearman correlation coefficient was 0.96 and 0.94 for Cl and CVAI, respectively. The mean absolute error (MAE) and standard deviation (STD) were 1.48 +/- 0.92 and 1.44 +/- 0.85 units for CI and CVAI, respectively.
b. Retrospective
- Study Type: Retrospective study comparing SoftSpot measurements of 2D rendered images (from 3D head scans) with direct measurements from 3D scans.
- Sample Size: 100 infants' head measurements
- Key Results: The Spearman correlation coefficient was 0.93 and 0.94 for Cl and CVAI, respectively. The mean absolute error (MAE) and standard deviation (STD) were 2.17 +/- 1.53 and 1.62 +/- 1.26 units for CI and CVAI, respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Prospective Study:
- Spearman correlation coefficient: CI = 0.96, CVAI = 0.94
- Mean Absolute Error (MAE) and Standard Deviation (STD):
- CI: 1.48 +/- 0.92
- CVAI: 1.44 +/- 0.85
- Retrospective Study:
- Spearman correlation coefficient: CI = 0.93, CVAI = 0.94
- Mean Absolute Error (MAE) and Standard Deviation (STD):
- CI: 2.17 +/- 1.53
- CVAI: 1.62 +/- 1.26
Predicate Device(s)
510(k) Exempt
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.
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September 28, 2021
PediaMetrix, Inc. Joshua Levin Regulatory Advisor 155 Gibbs Street, Suite 537 Rockville, Maryland 20850
Re: K212045
Trade/Device Name: SoftSpot™ Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: QQO Dated: June 26, 2021 Received: June 30, 2021
Dear Joshua Levin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212045
Device Name SoftSpot™
Indications for Use (Describe)
SoftSpot™ is intended to be used for cranial measurement for infants from 1 month up to 2 years of age in conjunction with other clinical methods.
SoftSpot™ is not intended to be used as a tool for preparing a helmet.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
A. Basic Information:
The submitter's name: PediaMetrix Inc
Address: 155 Gibbs St, Suite 537, Rockville, MD 20850
Telephone number: 240-670-0171
Contact: Joshua Levin, PhD.
The date the summary was prepared: 09-26-2021
B. 510(k) Number:
-
C. Device Proprietary and Established Names:
SoftSpot™ -
D. Regulatory Information:
-
- Classification Name: Manual surgical instrument for general use (21 CFR 878.4800)
-
- Classification: Class I
-
- Product code: QQO, Cranial measurement software
-
- Panel: Neurology
-
E. Indications for Use:
-
- Indications for use:
SoftSpot™ is intended to be used for cranial measurement for infants from 1 month up to 2 years of age in conjunction with other clinical methods. SoftSpot™ is not intended to be used as a tool for preparing a helmet
- Indications for use:
-
- Special conditions for use statement(s): For prescription use only.
F. Predicate Device:
-
- Predicate device name(s): Holtain-Kahn Caliper
-
- Predicate 510(k) number(s): 510(k) Exempt
-
- Product Code: FTY (Tape, Measuring, Rulers and Calipers)
-
- Classification Regulation: 21 CFR 878.4800
G. Device Description:
SoftSpot™ is a software that runs on a smartphone, tablet, PC, etc. and uses top view pictures of infant's head to measure cranial index (CI) and cranial vault asymmetry index (CVAI) similar to a mechanical caliper used by physicians which is also known as craniometer.
4
After the photo is taken, the head contour is identified and then, based on the current standards of measuring infants' head shape, characterizing parameters including the ratio of width over length (known as Cranial Index or CI) and the ratio of difference in diagonals over the larger one (known as Cephalic Vault Asymmetry Index or CVAI) are calculated (see Test Principle below).
The SoftSpot platform allows different users to upload or capture top view videos and photos of the infant's head. The user can be a physician/nurse (during well visits) or parents/guardians (between the visits). Once data are collected, they are sent to PediaMetrix Amazon Web Services (AWS) cloud. At PediaMetrix, the data analyst will use a windows-based software to download and analyze the data. The analysis includes conversion of the video into photos, standardization of the images (3x4, all nose up), selection of 5 good images, segmentation of the head contour and nose tip. Then, the software will calculate Cl and CVAI. Finally, a pdf report is generated with the results and sample top view photos and sent to the physician's account. Parents will also be notified when the results are ready. Then, the parent visits the physician (either in person or online) to discuss the results and next steps.
H. Measurand:
Cranial Index (CI) and Cephalic Vault Asymmetry Index (CVAI)
l. Measurement Principle:
The SoftSpot™ app calculates characterizing parameters including the ratio of width over length (known as Cranial Index or CI) and the ratio of difference in diagonals over the larger one (known as Cephalic Vault Asymmetry Index or CVAI) are calculated.
$$CI = \left(\frac{AP}{SD}\right) \times 100,$$
$$\text{A} \qquad \text{nD}$$
$$CVAI = \frac{AA - BB}{\max\left(AA, BB\right)} \times 100$$
- . AP is defined on the head contour by the line that goes through the nose tip and center of the head contour.
- . SD is defined by the line perpendicular at the midpoint of AP and intersecting the headcontour.
- AA and BB are defined by the intersection of the head contour and the lines that go through the center of the head contour at +/-40 degrees relative to AP.
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| Predicate Comparison - Similarities | ||
|---|---|---|
| Item | Device | |
| SoftSpot | Predicate | |
| Holtain-Kahn Caliper | ||
| Regulation | 21 CFR 878.4800 | 21 CFR 878.4800 |
| Product Code | TBD | FTY |
| Classification | Class I | Class I |
| Intended | ||
| Use/Indications for Use | Used for cranial measurements in | |
| conjunction with other clinical methods. | Same as SoftSpot | |
| Analytes measured | Cranial measurements | Same as SoftSpot |
J. Comparison of Technological Characteristics with the Predicate Device:
| Predicate Comparison - Differences | ||
|---|---|---|
| Item | Device | |
| SoftSpot | Predicate | |
| Holtain-Kahn Caliper | ||
| Intended Use | ||
| Population | Infants from 1 month to 2 years of age | Not specified |
| Measurement method | Software that uses pictures of the head to provide cranial measurements | Physical measurement of cranial parameters |
| Prescription/OTC | For prescription use; images may be collected by clinicians or parents/guardians | Not specified |
K. Performance Data:
1. Clinical Studies:
a. Prospective
For the prospective evaluation of our measurement tool, PediaMetrix compared measurements taken with the SoftSpot™ app to the measurements taken by clinicians using a standard caliper similar to the predicate device. A comparative study was performed using 25 infants (age range 3 to 12 months). Data were collected by a physical therapist in a plagiocephaly clinic at the University of Pittsburgh Children Hospital from their typical patient population. The Spearman correlation coefficient was 0.96 and 0.94 for Cl and CVAI, respectively. The mean absolute error (MAE) and standard deviation (STD) were $1.48 \pm 0.92$ and $1.44 \pm 0.85$ units for CI and CVAI, respectively.
b. Retrospective
We also compared SoftSpot measurements of 2D rendered images (from 3D head scans) with direct measurements from 3D scans of the head from patients with cranial deformities in a retrospective study using 100 infants' head measurements along with their 3D scans (in .stl format). Data were collected from patients aged 3-20 months with deformational plagiocephaly and brachycephaly (DPB) in a helmet clinic at Singapore. The Spearman correlation coefficient
6
was 0.93 and 0.94 for Cl and CVAI, respectively. The mean absolute error (MAE) and standard deviation (STD) were $2.17 \pm 1.53$ and $1.62 \pm 1.26$ units for CI and CVAI, respectively.
Conclusions: L.
The proposed clinical studies demonstrated that the device can function as intended for the intended population (infants 1 months to 2 years of age) and that it can be used to measure Cl and CVAI with accuracy comparable to the predicate device. This supports that the device is substantially equivalent to the predicate device.