(75 days)
Not Found
Not Found
No
The device description and intended use describe a purely mechanical instrument for physical examination, with no mention of software, image processing, or AI/ML terms.
No
The device is used for examination and visualization, which are diagnostic purposes, not for treating a disease or condition.
No
The device is described as an endospeculum used to expand the scope of routine gynecological examinations, permitting thorough examination and direct visualization. It is a tool for inspection, not for diagnosing a condition or disease.
No
The device description clearly states the device is made of stainless steel and describes physical components like blades, handles, and tips, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "Endospeculum used only to expand the scope of routine gynecological examinations." It is a physical instrument used to visualize anatomical structures (urethra and cervix) and manipulate tissue.
- No Sample Analysis: There is no mention of the device collecting or analyzing any biological samples. Its function is purely mechanical for visualization and access.
Therefore, the Gynex Endospeculum falls under the category of a surgical or examination instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the urethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.
Product codes (comma separated list FDA assigned to the subject device)
85HCZ, 85KNA
Device Description
General Description. The Gynex Endospeculums are made of 300 series instrument grade stainless steel. There are two styles, plain handle and ratchet handle. Both have "gold" plate handles. Tip sizes are 3mm and 4mm for both handle types. Overall length of both types is 270mm (approx. 10 in.). The device is essentially identical to the Kogan endospeculum listed above. The blade tips are spring closed and pressing the handles together opens spreads the tips to compress the cervical wall and expand the cervical os or urethra for inspection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, urethra, uterus
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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K980237 g 1 of 3
rely and nformation Section 510/k
GYNEX Corporation
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
APR - 8 1998
1. Device Name:
Gynex Endospeculum Trade Name: Common Name: Endospeculum Classification Name: Gynecological surgical forcep
- Establishment Name & Registration Number: 2.
Name: GYNEX Corporation Number: 3032109
Classification: 3.
& 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, 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) Classfication. Class II (performance standards).
Device Class: Class II Classification Panel: Ob/Gyn Devices Panel Product Code: 85HCZ
19
1
Preamendments Device: 4.
-
- Kogan Endospeculum, Gynecology, Obstetrics, V. Mueller, The Surgical Armamentarium, 1973., pp. 193.
5. Device Description:
General Description. The Gynex Endospeculums are made of 300 series instrument grade stainless steel. There are two styles, plain handle and ratchet handle. Both have "gold" plate handles. Tip sizes are 3mm and 4mm for both handle types. Overall length of both types is 270mm (approx. 10 in.). The device is essentially identical to the Kogan endospeculum listed above. The blade tips are spring closed and pressing the handles together opens spreads the tips to compress the cervical wall and expand the cervical os or urethra for inspection.
Intended Use. The endospeculum is used only to expand the scope of routine gynecological Fenestrated blades and finger rings bend outwards in opposite directions examinations. permitting thorough examination of the urethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.
6. Applicant Name & Address:
GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052
Company Contact: 7.
Mr. Steve Angelo, President GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052 425.882.1179 * 425.895.0115 - fax
8. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 1000 Burnett Av., Suite 450 Concord, CA 94520 510.356.2640 - 510.356.2654 - fax
ਰੇ. Voluntary Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, GYNEX Corporation. Standard Operating Procedures (SOP), vendor certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.
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K980237 fg3f3
| 10. Comparison Table! | |||
|---|---|---|---|
| FEATURE | Gynex Endocervical Speculum | Pudendal/Paracervical Needle & | |
| Potocky Needle | SE? | ||
| Indications for | |||
| Use(s): | Examination of the cervix and | ||
| urethra | Examination of the cervix and | ||
| urethra | YES | ||
| Design: | Plain & ratchet lock handles | ||
| Spring closed | |||
| Fenestrated tips | Plain handles | ||
| Spring closed | |||
| Fenestrated tips | Yes | ||
| Sterilization | |||
| Method: | Steam Autoclave | Steam Autoclave | NO & |
| YES | |||
| Sizes: | 270mm long (± 10 in.) | ||
| 3mm & 4mm tips | |||
| plain & ratchet handle | 9.75 in. long | ||
| 3-4mm | |||
| Plain handles | YES | ||
| Material: | 302 Stainless steel | 302 Stainless Steel | YES |
| Country of | |||
| Origin: | Germany | Germany | YES |
| Manufacturer: | Gynex Corporation | V. Mueller | YES |
| Product Code: | 84HCZ | 84HCZ | Yes |
| K - Number: | Pending | Preamendment | YES |
Storage, Packaging & Sterilization Information: 11.
The Graex Endospeculums are supplied in "clean only" condition and must be cleaned and sterilized prior to each use.
All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. Any shipping damaged product should be returned promptly. Product for use in the operating room must be processed opened, handled and placed into use following accepted operating room sterile technique.
Remove all labels and packaging materials before cleaning and sterilization. Wash the Gyzex Endospeculums thoroughly with hot water using a typical grade surgical instrument detergent or soap. Ultrasonic cleaners may be employed. Cleaning, rinsing and sterlization must be performed in accordance with usual hospital practice before first or any subsequent use.
The recommended sterilization process for the instruments is steam autoclave sterilization. The recommended sterilization cycle is: saturated steam at 270° F for 30 minutes. This is the typical or usual steam sterilization cycle use for surgical instruments. Use of this cycle will produce a Sterility Assurance Level (SAL) of at least 10 . Validation of the recommended sterilization cycle will be achieved via the overkill method, the Kilmer method or a modified AAMI ST32 method 3, protocol B as selected by the biological testing laboratory.
3
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health. The logo features the words "DEPARTMENT OF HEALTH" in a vertical orientation on the left side of the image. To the right of the text is a symbol that consists of three stylized human figures facing to the right. The figures are represented by simple, curved lines, and they are stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gynex Corporation c/o Mr. David W. Schlerf Re: K980237 Gynex Endospeculum Dated: January 20, 1998 Received: January 23, 1998 Regulatory Class: II 21 CFR 884.4530/Procode: 85 KNA
APR - 8 1998
Buckman Company, Inc. 1000 Burnett Avenue Suite 450 Concord, CA 94520
Dear Mr. Schlerf:
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 QS 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 542 of the Act for 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) 594-4613. 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 -র্তা
510(k) Number (if known): _ K 980237
Device Name(s):
GYNEX Endospeculum
Intended Use:
-
- Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the urethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
- Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the urethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.
Concurrence of CDRH, Office of Device Evaluation (ODE) Doler of Natt (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 9806 >> 510(k) Number Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional format 1-2-96) GYNEX-ENDO.doc 9