(47 days)
Not Found
No
The device description focuses on the material properties, design, and sterilization of a physical instrument, with no mention of software, algorithms, or data processing.
No
The device is described as an instrument used to expose the cervix during general gynecologic and electrosurgical procedures, which is a diagnostic or procedural aid, not a therapeutic intervention.
No
This device is a surgical instrument used to expose the cervix for general gynecologic and electrosurgical procedures; it does not diagnose a condition.
No
The device description clearly outlines a physical, reusable vaginal speculum made of plastic and stainless steel, intended for insertion into the vagina. It discusses material properties, sterilization methods, and physical design features, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be inserted into the vagina to expose the cervix for general gynecologic and electrosurgical procedures. This is a physical manipulation and visualization of an anatomical site, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties of the speculum (material, reusability, sterilization). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, test strips, or analytical methods described.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This vaginal speculum is a tool for physical examination and procedures, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures and is inserted into the vagina to expose the cervix. It is supplied non-sterile and is intended to be autoclavable for 100+ cycles.
Product codes (comma separated list FDA assigned to the subject device)
85HIB
Device Description
The Ultimate Reusable, Plastic Vaginal Speculum is a device used to expose the interior of the vagina during general gynecologic and electrosurgical procedures. The non-conductive, specialized plastic stops dangerous grounding of the electrical current that a metal would not. The stainless steel metal parts will not rust and are away from the operating area. The three main parts are injection molded from a plastic called ULTEM, a General Electric Company product used for many years in the manufacturing of medical devices, where high temperature and chemical interaction is a concern. The speculum has been autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles and there is no coating to breakdown, crack, chip, or peel. The color is pink to stop light reflection (as opposed to white) and still light enough to show any surface damage that might happen in use. The surfaces are polished and all sharp edges are removed for the protection of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina, Cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Substantial equivalence for this device is based on design, operation, intended use, materials, components and performance claims. Testing that was performed on the Ultimate Reusable, Plastic Vaginal Speculum indicates that the devices are substantially equivalent in their performance and design of operation.
Hazard analysis evaluations performed on the Ultimate Reusable, Plastic Vaginal Speculum indicated that there were no new hazards presented with the use of the Ultimate Reusable, Plastic Vaginal Speculum as compared to the predicate device.
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.
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.
0
SEP 2 9 1999
510(k) Premarket Notification Submittal
Wallach Surgical Devices, Inc.
Ultimate Reusable, Plastic Vaginal Speculum
SECTION 2 – Page 2 of 3
510(k) Safety and Effectiveness Summary
| Applicant: | Wallach Surgical Devices, Inc.
235 Edison Road
Orange, CT 06477 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Registration #: | 1219739 |
| Contact: | Michael Malis |
| Phone: | 203-799-2000 |
| Fax: | 203-799-2002 |
| Trade Name: | Wallach's Ultimate Reusable, Plastic Vaginal Speculum |
| Device Generic Name: | Speculum. |
| Classification Name: | Speculum, Vaginal, Nonmetal. |
| Classification: | Currently the device classification is Class II, under Product
Code 85HIB, Regulation Number 884.4530, 21 CFR. |
Predicate Devices to which we are claiming substantial equivalence:
Adept-Med's Gravespec Reusable Nonmetal, Vaginal Speculum, K935636, 03/25/94. CooperSurgical's Prima Series, Vaginal LEEP Plastic Reusable Specula, K951898, 12/11/95.
Product Description:
The Ultimate Reusable, Plastic Vaginal Speculum is a device used to expose the interior of the vagina during general gynecologic and electrosurgical procedures. The non-conductive, specialized plastic stops dangerous grounding of the electrical current that a metal would not. The stainless steel metal parts will not rust and are away from the operating area. The three main parts are injection molded from a plastic called ULTEM, a General Electric Company product used for many years in the manufacturing of medical devices, where high temperature and chemical interaction is a concern. The speculum has been autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles and there is no coating to breakdown, crack, chip, or peel. The color is pink to stop light reflection (as opposed to white) and still light enough to show any surface damage that might happen in use. The surfaces are polished and all sharp edges are removed for the protection of the patient.
1
510(k) Premarket Notifi Wallach Surgical Devices, Inc. Ultimate Reusable, Plastic Vaginal Speculum SECTION 2 - Page 3 of 3
Indications for Use:
The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures and is inserted into the vagina to expose the cervix. It is supplied non-sterile and is intended to be autoclavable for 100+ cycles.
Safety and Performance:
Substantial equivalence for this device is based on design, operation, intended use, materials, components and performance claims. Testing that was performed on the Ultimate Reusable, Plastic Vaginal Speculum indicates that the devices are substantially equivalent in their performance and design of operation.
Hazard analysis evaluations performed on the Ultimate Reusable, Plastic Vaginal Speculum indicated that there were no new hazards presented with the use of the Ultimate Reusable, Plastic Vaginal Speculum as compared to the predicate device.
| | Wallach'Surgical's
Ultimate Reusable, Plastic
Vaginal Speculum
K
[this 510(k)] | CooperSurgical's
Prima Series
Vaginal LEEP
Reusable Plastic Speculum
K951898
12/11/95. | Adept-Med Int'l, Inc.
Gravespec®
Reusable,
Plastic Speculum
K935636
3/25/94 |
|---------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Materials | Ultem Plastic. | Equivalent | Similar |
| Sterilization | Autoclavable / Reusable. | Equivalent | Similar |
| Design | 1. Plastic Injection Molded.
2. Non-conductive.
3. No coating to breakdown, crack,
chip, or peel. | 1. Equivalent
2. Equivalent
3. Equivalent | 1. Equivalent
2. Equivalent
3. Equivalent |
| Intended Use | To assist in electrosurgical procedures
to expose the interior of the vagina. | Equivalent | Equivalent |
| Where Used | By a Physician. | Equivalent | Equivalent |
SUBSTANTIAL EQUIVALENCE CHART
Conclusion:
Based on the indications for use, technological characteristics and comparison to a currently marketed device, the Ultimate Reusable, Plastic Vaginal Speculum has been shown to be safe and effective for its intended use.
SummaryURSpeculum.doc
2
Image /page/2/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a symbol consisting of three stylized human figures or profiles facing to the right, with flowing lines above them.
SEP 2 9 1999
Mr. Michael Malis General Manager Wallach Surgical Devices, Inc. 235 Edison Road Orange, Connecticut 06477
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K992736 Wallach Ultimate Reusable, Plastic Vaginal Speculum Dated: August 10, 1999 Received: August 13, 1999 Regulatory Class: II 21 CFR $884.4530/Procode: 85 HIB
Dear Mr. Malis:
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 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). 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 (QS) 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 531 through 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
- [Image]002
9/15/99
go.
Wallach Surgical Devices, Inc SECTION 5
Page of 1
510(k) Number (if known): K992736
Wallach Ultimate Reusable, Plastic Speculum Device Name:
Indications For Use:
The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for The villabor of climited on the consideres. This product is inserted into the vagina to expose the cervix.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number.
....