(63 days)
Not Found
Not Found
No
The description focuses on mechanical components and function, with no mention of AI/ML terms, image processing, or data analysis.
No.
The device's intended use is "exposing the interior of the vagina," which is a diagnostic or observational purpose, not a therapeutic one. It functions like a speculum, which is used for examination, not treatment.
No
The device is used for exposing the interior of the vagina, which is a functional purpose, not for diagnosing a condition. It is described as constructurally equivalent to a speculum, which is an instrument used to hold open a body cavity for examination.
No
The device description explicitly details physical components made of injected molded parts, blades, and a window trap, 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 "for exposing the interior of the vagina." This is a physical manipulation of the body for visualization, not a test performed on a sample taken from the body.
- Device Description: The description details a physical instrument used for examination. There is no mention of reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on laboratory results.
This device appears to be a medical device used for physical examination, specifically a vaginal speculum.
N/A
Intended Use / Indications for Use
- The intended use is to expose the interior of the vagina
- The intended use is to maintain a clear and protected area of view
This device is to be used for exposing the interior of the vagina.
Product codes (comma separated list FDA assigned to the subject device)
85 HIB
Device Description
- The device is made of injected molded parts.
- The device assembly includes a window trap for pins to snap together
- The instrument has levels in the windows to lock positions as desired by the expanding vertical blades
- The lateral blade protectors act to prevent lateral walls from cascading into view area.
- Lateral protector blades are same thickness of vertical blades thus act as rigid barriers
- Lateral protector blades conform with the design of vertical blade that provide rigid conforming structures that allows smooth unchanged entrance
The device once snapped together do not require any further assembly - The device is for single use only
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)
Constructurally equivalent to the Cooper Speculum which has already been subjected to millions of applications
The Nu-Spec D complies with all acceptance criteria listed above.
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.
0
KO12859
Page 1 of 2
OCT 2 6 2001
Date
SOL WEISS, M.D., INC. 7012 RESEDA BOULEVARD, SUITE A RESEDA, CALIFORNIA 91335 TELEPHONE (818)346-1515 FAX (818)705-5300
510(k) Summary
August 22, 2001
Manufacturer:
Not applicable at time of submission. Established Registration will be submitted upon determination of manufacturer
Owner:
Sol Weiss, M.D. 7012 Reseda Boulevard Suite A Reseda, California 91335
Sol Weiss, M.D.
Contact Person:
Device Trade Name:
Vaginal Speculum disposable Common Name:
Nu-Spec D
Speculum Classification Name:
Regulatory Reference: 884.4530(17)
Description (Exhibit F1, F2 and G):
- The device is made of injected molded parts .
- The device assembly includes a window trap for pins to snap together ●
- The instrument has levels in the windows to lock positions as desired . by the expanding vertical blades
- The lateral blade protectors act to prevent lateral walls from cascading ● into view area.
- Lateral protector blades are same thickness of vertical blades thus act � as rigid barriers
- Lateral protector blades conform with the design of vertical blade that . provide rigid conforming structures that allows smooth unchanged entrance
The device once snapped together do not require any further assembly
1
- 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
510(k) Summary
-
The device is for single use only
Intended use: -
The intended use is to expose the interior of the vagina ●
-
The intended use is to maintain a clear and protected area of view ●
Physical / Technical Comparison:
- Have the same intended use .
- Manufactured through injection molding ●
- Made with same materials .
- Maintain same rigidity for vaginal viewing
- Both have clear plastic for viewing
- Share the same release mechanisms .
- Share the same opening / closing and locking mechanisms in use .
- Both have same configurations for handling and gripping
Differences:
- The lateral wall protectors keep viewing clear �
- Lateral wall protectors afford less chances of injuring walls of vagina ● during procedures
- Do not alter the utilization of the instrument while affording safety ● and effectiveness
Performance Summary:
- Constructurally equivalent to the Cooper Speculum which has already . been subjected to millions of applications
The Nu-Spec D complies with all acceptance criteria listed above.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and healing. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2001
Sol Weiss, M.D. Sol Weiss, M.D., Inc. 7012 Reseda Boulevard Suite A RESEDA CA 91335
Re: K012859
Trade/Device Name: Nu-Spec DTM Vaginal Speculum or WEISS SPEC-D Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: August 22, 2001
Dear Dr. Weiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device w onever 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 for ass battled in the enactment date of 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 I ou may, ateres, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Received: August 24, 2001
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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 11 you decir office of Compliance at 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 by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/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
4
510(k) Number (if known):
Device Name:
Indications for use:
This device is to be used for exposing the interior of the vagina.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012859
and Radiological Devices
510(k) Number K012859
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)