(81 days)
The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is in ended to be used for hair transplantation on the scalp. The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is indicated where patients require one or more hair grafting sessions during which multiple grafts have to be implanted.
The RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel) is a disposable mechanical device designed to facilitate a hair transplant. It consists of a circular Carousel designed to house hair grafts, a sharp end designed to create an opening in the skin of the scalp and a button end that activates the moving parts within the Carousel. The CAROUSEL consists of a stainless steel blade and the body composed of Lustran 348 resin.
The provided submission describes limited studies to support the device. Here's a breakdown based on the information provided and how it aligns with your requested criteria:
Device: RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device does not overtly harm tissue or patient compared to predicate/manual method. | In vitro: No difference in gross morphology, intact and undamaged implants, no significant histological difference (Carousel resulted in more uniform depth). In vivo (human): No reported adverse events, "much less bleeding by the Carousel method" (implying less trauma), "no difference between those made with the Carousel and those made with the conventional appeared" (referring to post-operative wounds). |
| Effectiveness/Functionality: Device facilitates hair transplantation. | In vitro: Successfully implanted grafts. In vivo (human): Successfully implanted grafts, "much shorter time needed for graft placement" with Carousel (compared to manual), "no difference in the rate of growth or the number of hairs" between Carousel and manual methods. |
| Substantial Equivalence: Device is equivalent to predicate devices in terms of safety and effectiveness. | Performance tests validated its safety and effectiveness and support the claim of substantial equivalence to the Calivitron Hair Transplant System and Padgett Hair Transplant Punch. The Carousel's differences (carousel feature for graft storage and speed) do not impact safety and effectiveness negatively. |
2. Sample size used for the test set and the data provenance
- In vitro study: Not explicitly stated, but involved "biopsy specimens of groups implanted manually and with the Carousel under loop magnification".
- In vivo (human) study: One (1) human subject.
- Data Provenance: Not explicitly stated, but the human study involved a patient. Given the context of a 510(k) submission to the FDA, it is retrospective in nature (reporting on completed studies). The country of origin is not specified but is likely the U.S. as it's an FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The "visual inspection" and "histologic evaluation" were likely performed by medical professionals, but their number, qualifications, and role in establishing ground truth (e.g., comparing to a gold standard) are not detailed.
4. Adjudication method for the test set
Not applicable/not explicitly stated. The studies describe observations and evaluations, but not a process of adjudicating differing expert opinions on a specific outcome (e.g., presence of a disease).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument.
7. The type of ground truth used
- In vitro study: Gross morphology and histological evaluation of porcine skin biopsy specimens. The comparison was against manually implanted grafts.
- In vivo (human) study: Clinical observations of bleeding, operative time, post-operative wound appearance, rate of hair growth, and number of hairs. The comparison was against a manual implantation method (Nokor needle and manual forceps).
8. The sample size for the training set
Not applicable. This device is a physical surgical instrument, not a learned algorithm. There is no concept of a "training set" in the context of this submission.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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K972918
OCT 2 7 1997
Apex Medical Products 9911 W. Pico Boulevard, Suite 301 Los Angeles, CA 90035 (800) 683-8673
XI. SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION
ESTABLISHMENT REGISTRATION NUMBER:
MANUFACTURER IDENTIFICATION:
OFFICIAL CONTACT PERSON:
Apex Medical Products, L.L.C. 9911 West Pico Blvd., Suite301 Los Angeles, CA 90035
Pending
Surgical Technology Inc. 292 East Lafayette Road St. Paul, MN 55107
Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac . MD 20854
Tel. : (301) 279 -2899 Fax : (301) 294-0126
DATE OF PREPARATION OF THIS SUMMARY:
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME AND REFERENCE:
PROPOSED REGULATORY CLASS:
DEVICE PRODUCT CODE:
PANEL CODE:
August 6, 1997
RAPID FIRE HAIR IMPLANTER CAROUSEL™
Hair Transplant Facilitator
Manual Surgical Instrument (21 CFR, Section 878.4800) Class I
GAH
80 SU
000113
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DESCRIPTION OF DEVICE:
INTENDED USE:
INDICATIONS FOR USE:
PREDICATE DEVICE:
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The RAPID FIRE HAIR IMPLANTER CAROUSEL™
(Carousel) is a disposable mechanical device designed to facilitate a hair transplant. It consists of a circular Carousel designed to house hair grafts, a sharp end designed to create an opening in the skin of the scalp and a button end that activates the moving parts within the Carousel.
The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is in ended to be used for hair transplantation on the scalp.
The RAPID FIRE HAIR
IMPLANTER CAROUSEL™ is indicated where patients require one or more hair grafting sessions during which multiple grafts have to be implanted.
The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is substantially equivalent to the Calivitron Hair Transplant System (manufactured by Medicamat, S.A.)
and the Padgett Hair Transplant Punch (manufactured by Padgett Instruments){
Both the PADGETT and the CAROUSEL are non-powered simple units that use a stainless steel device for graft cutting. The CAROUSEL differs from the PADGETT in having a carousel feature that facilitates storage of the graft and speeds up the surgical procedure. These differences between these devices do not impact the safety and effectiveness in a significant way except for the improvements relating to the carousel noted above.
The CALVITRON also uses a four bladed scalpel device but utilizes a complex electrically powered system to
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SUMMARY OF STUDIES:
provide for aspiration, compression and micromotors. The CAROUSEL is much simpler in design than the CALVITRON. In contrast the 48 kg CALVITRON, which lists 11 components to its system, including a control panel, vacuum and compression connectors, sterile arm unit, etc., the CAROUSEL is a hand-held unit roughly the size of a ball point pen.
The CAROUSEL consists of a stainless steel blade and the body composed of Lustran 348 resin. The predicate devices also have stainless steel blades which act as the patient contacting surfaces.
Performance test results on the CAROUSEL including in vitro tests on porcine skin and a test on a human subject, validated its safety and effectiveness. In the in vitro study, visual inspection of the biopsy specimens of groups implanted manually and with the Carousel under loop magnification showed no difference in the gross morphology of the implants. In both the test and control groups the implants were positioned identically in the dermis and in both groups the implants appeared intact and undamaged. Histologic evaluation revealed no significant difference between the implanted tissue of both groups with the exception that the hair follicles implanted with the Carousel were at a somewhat more uniform depth within the porcine tissue than those of the control group.
400 grafts were implanted on the right side of a patient's scalp approximately 1 cm behind the right frontal hairline. The left side was implanted manually, using a Nokor needle and manual forceps. There was much less bleeding by the Carousel
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method, resulting in a much shorter time nectical for grafi placement. The post operative wounds showed no difference between those made with the Carousel and those made with the conventional appeared. No difference in the rate of growth or the number of hairs was seen villes each of the two groups were : ーで使
.
000116
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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1997
Apex Medical Products, L.L.C. c/o Norman F. Estrin, Ph.D., RAC Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
K972918 Re:
Trade Name: Rapid Fire Hair Implanter Carousel™ Regulatory Class: I Product Code: GAH Dated: August 7, 1997 Received: August 7, 1997
Dear Dr. Estrin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Norman F. Estrin, Ph.D., RAC
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Acolle
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K9722918
Rapid Fire Hair Implanter Carousel™ Device Name:
Indications for Use:
The Rapid Fire Hair Implanter Carousel™ is to be used for hair transplantation on the scalp. Its use is indicated where patients require one or more hair grafting sessions during which multiple grafts have to be implanted.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-the-Counter U
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
972918
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.