21 CFR 890.5670 — Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5670
Identification
A hand-held internal therapeutic massager device is a prescription device intended for medical purposes to manually provide direct pressure applied to localized areas of pain or tenderness in the myofascial tissue associated with chronic pelvic pain syndromes. The device is inserted rectally or vaginally and provides quantitative feedback to the user of the applied force to the target tissue.
Classification Rationale
Class II (special controls). The device, when it is for prescription use only with a quantitative feedback mechanism and a disposable covering, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OSD | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature | 2 | 1 | |
| QKD | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use | 2 | 0 |
Special Controls
OSD — Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
In combination with the general controls of the FD&C Act, the AHIP Internal Trigger Point Wand is subject to the following special controls: - 1. The labeling must include adequate directions for use, including prescribing information, to ensure safe and effective use by the patient; - 2. Appropriate analysis/testing must validate electromagnetic compatibility (EMC), electrical safety and mechanical safety; - 3. Non-clinical performance testing must demonstrate a reasonable assurance of safety and effectiveness. including mechanical durability and accurate feedback mechanism: - 4. Appropriate software verification, validation, and hazard analysis must be performed: and - 5. All elements of the device that may contact the patient must be demonstrated to be biocompatible.
De Novo Order DEN100023
OSD — Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
*Classification.* Class II (special controls). The device, when it is for prescription use only with a quantitative feedback mechanism and a disposable covering, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. The special controls for this device are:(1) Labeling must include adequate directions for use. (2) Non-clinical performance testing must demonstrate electromagnetic compatibility (EMC), electrical safety and mechanical safety. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical durability; and (ii) Accuracy of the feedback mechanism. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
eCFR
OSD — Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
(1) Labeling must include adequate directions for use. (2) Non-clinical performance testing must demonstrate electromagnetic compatibility (EMC), electrical safety and mechanical safety. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical durability; and (ii) Accuracy of the feedback mechanism. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
Ecfr Llm
QKD — Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
*Classification.* Class II (special controls). The device, when it is for prescription use only with a quantitative feedback mechanism and a disposable covering, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. The special controls for this device are:(1) Labeling must include adequate directions for use. (2) Non-clinical performance testing must demonstrate electromagnetic compatibility (EMC), electrical safety and mechanical safety. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical durability; and (ii) Accuracy of the feedback mechanism. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
eCFR
