K013817 · Sol Weiss MD, Inc. · HIB · Dec 21, 2001 · Obstetrics/Gynecology
Device Facts
Record ID
K013817
Device Name
GLO-SPEC
Applicant
Sol Weiss MD, Inc.
Product Code
HIB · Obstetrics/Gynecology
Decision Date
Dec 21, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4530
Device Class
Class 2
Indications for Use
The intended use is interconnection of devices for transmission of light. The intended use is to illuminate area of view.
Device Story
Glo-Spec is a portable connector device designed to facilitate light transmission for vaginal visualization during clinical procedures. It functions by interconnecting light sources (e.g., penlights) to a vaginal speculum. Unlike predicate devices that integrate the connector into the handle, the Glo-Spec is a separate component that rests in the lateral wall protector of the speculum. This positioning keeps the connector above the area where bleeding may occur, reducing contamination risk and preventing interference with the clinician's view. The device is manufactured via injection molding using materials identical to the predicate. It allows for the use of various external light sources, whereas the predicate is restricted to proprietary transformers. The device is intended for use by physicians or clinical staff in a medical setting to improve visualization during gynecological examinations.
Clinical Evidence
Bench testing only. The device was determined to be structurally equivalent to the predicate device, which has been subjected to millions of applications.
Technological Characteristics
Injection-molded plastic connector; designed for light transmission; features windows for heat dissipation; non-contact with body surface; modular design allows compatibility with various external light sources.
Indications for Use
Indicated for use as a connector for light transmission to illuminate the vaginal area during gynecological procedures.
Regulatory Classification
Identification
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
Special Controls
*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Predicate Devices
Welch Allyn's Kleenspec
Submission Summary (Full Text)
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K013817
Page 1 of 2
## SOL WEISS, M.D., INC. 7012 RESEDA BOULEVARD, SUITE A RESEDA, CALIFORNIA 91335 TELEPHONE (818)346-1515 FAX (818)705-5300
DEC 2 1 2001
11/12/01 Page 7b
510(k) Summary
Intended use:
- The intended use is interconnection of devices for transmission of light ●
- The intended use is to illuminate area of view .
Physical / Technical Comparison:
- Have the same intended use of transmitting light ●
- Manufactured through injection molding ●
- Made with same materials ●
- Maintain same rigidity of part ●
- Both have clear plastic for viewing ●
- Both have windows that allow heat to escape.
Differences:
- Rests in the lateral wall protector to keep viewing clear ●
- Rests in the lateral wall protector affording less chance of interfering with ● view of the vagina during procedures
- Does not alter the utilization,safety or efficacy of the Nu-Spec D while . affording light for visualization
- Glo-Spec portable connector has no body or membrane contact. Kleenspec . connector as part of the handle has contact with the body surface.
- Glo-Spec portable connector will allow for other different light sources to be . used (i.e. penlights, etc.) Welch Allyn's Kleenspec only permits their transformer and equipment as a light source.
- Glo-Spec portable connector place is above and out of area where bleeding . may contaminate this device
Performance Summary:
- Constructurally equivalent to the Welch Allyn's Kleenspec, and other . predicate devices which have already been subjected to millions of applications
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K013817
Page 2 of 2
## SOL WEISS, M.D., INC. 7012 RESEDA BOULEVARD, SUITE A RESEDA, CALIFORNIA 91335 TELEPHONE (818)346-1515 FAX (818)705-5300
11/12/01 Page 7c
The Glo-Spec complies with all acceptance criteria listed above.
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2001
Sol Weiss, M.D. Sol Weiss, M.D., Inc. 7012 Reseda Boulevard, Suite A RESEDA CA 91335
Re: K013817
Trade/Device Name: Glo-SpecTM Connector, Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstretric-gynecologic specialized manual instrument Regulatory Class: II
Product Code: 85 HIB Dated: November 12, 2001 Received: November 16, 2001
Dear Dr. Weisse:
We have reviewed your Section 510(k) premarket notification of intent to market the devices indication we nave reviewed your Section 310(x) presidentially equivalent (for the indications felerenced above and nave docemined in arketed predicate devices marketed in interstate for use stated in the encrosule) to regally many than the of the Medical Device American by to commerce prior to May 28, 1776, the enactitions with the provisions of the Federal Food, Drug, devices that have been icclassified in accerazivel of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl and Cosment Act (Act) that do not require spect to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (sec above) nito extine major regulations affecting your device can be it may be subject to additional controls. Little 21, Parts 800 to 898. In addition, FDA may found in the Code of Peacharter concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DTS Issualite of a complies with other requirements of the Act that IDA has made a decorminations administered by other Federal agencies. You must of any Federal Statutes and regulations and limited to: registration and listing Comply with an the Act 3 requirements, metalling, and manufacturing practice requirements as set anisa (21 CFR Part 807), laborag (21 CFR Part 820); and 1f applicable, the electronic forul in the quality systems (QD) rogisemions 531-542 of the Act); 21 CFR 1000-1050.
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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 predication. The I Dr 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), please IT you desire specific acrisi as a one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Office or Setting to premarket notification" (21 CFR Part 807.97). Other general information on of reservere to promained from the Division of Small Manufacturers, your roopensional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ K 013 81 3 _______________________________________________________________________________________________________________________________________
Device Name:___Glo-Spec; alternative name is Glo-Speck
Indications for use:
The intended use is the interconnection of devices for transmission of light.
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergmann
| (Division | |
|--------------------------|----------|
| Division of | 1 |
| and Radiological Devices | |
| 510(k) Number | K013 817 |
Prescription Use_レ (Per 21 CFR 801.109) OR
Over-The-Counter Use -
(Optional Format 1-2-96)
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