Last synced on 23 September 2022 at 11:05 pm

Cranial Measurement Software

Page Type
Product Code
Definition
Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.
Physical State
Software-only device for recording, storing, and analyzing images to obtain physical measurements of the head and to display measurement results. Does not include software for preparing helmets or other cranial orthosis devices, nor any clinical interpretation of the measurements.
Technical Method
Uses software-based analysis of images obtained from a camera to calculate physical measurements of the head.
Target Area
Head
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4800
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4800 Manual surgical instrument for general use

§ 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.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001; 86 FR 56204, Oct. 8, 2021; 86 FR 66188, Nov. 22, 2021]

Cranial Measurement Software

Page Type
Product Code
Definition
Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.
Physical State
Software-only device for recording, storing, and analyzing images to obtain physical measurements of the head and to display measurement results. Does not include software for preparing helmets or other cranial orthosis devices, nor any clinical interpretation of the measurements.
Technical Method
Uses software-based analysis of images obtained from a camera to calculate physical measurements of the head.
Target Area
Head
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4800
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4800 Manual surgical instrument for general use

§ 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.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001; 86 FR 56204, Oct. 8, 2021; 86 FR 66188, Nov. 22, 2021]