(216 days)
Not Found
No
The device description focuses on mechanical components and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is used to retract and expose the vagina during diagnostic and therapeutic procedures, but it does not directly provide therapy itself. It is a surgical instrument.
No
The device is described as a retraction and exposure tool for the vagina, used during diagnostic and therapeutic procedures. It does not perform any diagnostic function itself. Its purpose is to facilitate the ability of a clinician to perform diagnostics.
No
The device description clearly describes a physical medical device consisting of a reusable weighted speculum handle and disposable blades. It does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures." This describes a physical tool used for visualization and access during procedures performed on the patient's body.
- Device Description: The description details a physical speculum with blades and a weighted handle. It's a mechanical device used to manipulate tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with specimens in this way.
This device is a surgical instrument or medical device used for physical examination and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The G-SPEC™ Articulated Weighted Vaginal Speculum is intended for use to retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.
Product codes
85 HIB
Device Description
G-Spec™ Articulated Weighted Vaginal Speculum is supplied with single use disposable blades that attached to a 2 pound stainless steel weighted speculum handle. The disposable blades are supplied in three sizes: 9,11, and 13 centimeters And can be set to three positions relative to the weighted handle: 90, 80, and 70 degrees. The disposable blades snap fit into the reusable weighted speculum handle and are discarded after each use. The reusable weighted speculum handle is reusable and may be cleaned and resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medisul Disposable Vaginal Speculum, Marketing Perspectives, Inc.(K000414), Disposable Vaginal Speculum, Medical Action Industries, Inc. (k0022948), Kentex Disposable Vaginal Speculum, Kentron Health Care, K030693, Vag O Speculum, Panatrex, Inc. (K043950), Plastic Vaginal Speculum, Astralite Corp. (k# unknown), Auvard Weighted Vaginal Speculum, Cooper Surgical (exempt)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
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.
(b)
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.
0
GyNOVA, LLC
6 2006 APR
510(k)
August 24, 2005
Kosz420
510 (k) SUMMARY:
G-SpecTM Articulated Weighted Vaginal Speculum
- GyNOVA, L.L.C. 698 Middle Turnpike East Manchester, CT 06040
Contact Person: Don Guinan Date Summary Prepared: August 24, 2005
- Trade or Proprietary Name:
G-SpecTM Articulated Weighted Vaginal Speculum
-
- Common Name:
Vaginal Speculum
- Common Name:
- Classified Name:
Nonmetal vaginal speculum 21 CFR 884.4530
- Product Code: 85 HIB
Predicate Devices:
Medisul Disposable Vaginal Speculum, Marketing Perspectives, Inc.(K000414)
Disposable Vaginal Speculum, Medical Action Industries, Inc. (k0022948)
Kentex Disposable Vaginal Speculum, Kentron Health Care, K030693 Vag O Speculum, Panatrex, Inc. (K043950)
Plastic Vaginal Speculum, Astralite Corp. (k# unknown)
Auvard Weighted Vaginal Speculum, Cooper Surgical (exempt)
(4) Description of Device:
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August 29, 2005
G-Spec™ Articulated Weighted Vaginal Speculum is supplied with single use disposable blades that attached to a 2 pound stainless steel weighted speculum handle. The disposable blades are supplied in three sizes:
9,11, and 13 centimeters
And can be set to three positions relative to the weighted handle:
90, 80, and 70 degrees
The disposable blades snap fit into the reusable weighted speculum handle and are discarded after each use. The reusable weighted speculum handle is reusable and may be cleaned and resterilized.
(5) Intended Use:
The G-SPEC™ Articulated Weighted Vaginal Speculum is intended for use to retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.
- (6) Technolgical Characteristics:
The G-SPEC™ Articulated Weighted Vaginal Speculum consists of a single use plastic blade which attaches to a reusable weighted stainless steel handle. The blades are provided in three sizes and may be adjusted to four positions during use.
(7) Conclusion:
The G-SPEC™ Articulated Weighted Vaginal Speculum has the same intended use and the same basic technology as the predicates identified in the premarket notification submission. The new device contains in some combination similar/same features. materials, and design as the predicates and does not pose any new questions concerning safety and effectiveness.
510(k)
59 of 63
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
Don Guinan, Jr. Managing Director/Principal Owner GyNOVA LLC 698 Middle Turnpike East MANCHESTER CT 06040
Re: K052420
Trade/Device Name: G-SPEC™ Articulated Weighted Vaginal Speculum Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: March 6, 2006 Received: March 7, 2006
Dear Mr. Guinan:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/industry/support/index.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
4
GyNOVA, LLC
510(k)
August 29, 2005
Indications for Use
24 20 510(k) Number (if known):
G-SPEC™ Articulated Weighted Vaginal Speculum __ Device Name:
Indications for Use:
To retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052420
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