(83 days)
Not Found
No
The device description clearly states it is a "handheld mechanical device" with a "ratchet lock" and "retracting blades," indicating purely mechanical operation. There is no mention of software, algorithms, or any computational components that would suggest AI/ML.
No
The device is described as retracting the vagina for diagnostic and therapeutic procedures, but it does not directly provide a therapeutic effect itself. Its function is to facilitate other procedures.
Yes
Explanation: The device is intended for use in "diagnostic and therapeutic obstetrical and gynecological procedures," indicating its involvement in the diagnostic process.
No
The device description clearly states it is a "handheld mechanical device" with physical components like a handle, blades, and a ratchet lock, indicating it is a hardware device, not software-only.
Based on the provided information, the Patton Speculum™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures." This describes a physical manipulation of the body for visualization and access, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a mechanical device for physical retraction. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Mentions of reagents, assays, or laboratory procedures
The Patton Speculum™ is a surgical/procedural instrument used in vivo (within the body) to facilitate medical procedures.
N/A
Intended Use / Indications for Use
The Patton Speculum™ is intended for use to retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures.
Product codes
85 HIB
Device Description
The Patton Speculum™ is a handheld mechanical device with a pistol-grip handle, four retracting blades, and a ratchet lock. When the handle is squeezed, the blades move in such a way as to expand the cylindrical surface enclosing them.
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)
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
SEP -1 1999
510(k) Summary as required by 807.92(c) for Patton Speculum™ Prepared June 9, 1999
- Submitted by: Patton Medical Corporation 1000 Westbank Drive, Suite 5A200 Austin. Texas 78746 512 329-0469 Fax 512 367-1243
- Contact Person: Michael T. Patton President
- Device Trade Name: Patton Speculum™
- Common Name: vaginal speculum
Classification: nonmetal vaginal speculum
- Medscand Disposable Plastic Vaginal Speculum (K984211), Predicate Devices: manufactured by Medscand USA. Inc., P.O. Box 7733. Hollywood, FL 33081-1733 and the Newport Lateral Vaginal Retractor (K891351), manufactured by Simpson/Bayse, Inc., 430 Avre Street, Wilmington, DE 19804.
Description of Device:
The Patton Speculum™ is a handheld mechanical device with a pistol-grip handle, four retracting blades, and a ratchet lock. When the handle is squeezed, the blades move in such a way as to expand the cylindrical surface enclosing them.
Intended Use of Device:
The Patton Speculum™ is intended for use to retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures.
Substantial Equivalence to Predicate Device:
The Patton Speculum™ is substantially equivalent to the combination of two vaginal retractors, or specula. The first is the traditional two-bladed speculum, e.g., Medscand Disposable Plastic Vaginal Speculum (K984211), manufactured by Medscand USA, Inc. The second is the lateral vaginal retractor, e.g., the Newport Lateral Vaginal Retractor (K891351), manufactured by Simpson/Bayse, Inc.
1
Image /page/1/Picture/0 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 an abstract image of a stylized eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 1999
Mr. Michael T. Patton President Patton Medical Corporation 1000 Westbank Drive, Suite 5A200 Austin, TX 78746
Re: K991963 Patton Speculum™ Dated: June 9, 1999 Received: June 10, 1999 Regulatory Class: II 21 CFR §884.4530/Procode: 85 HIB
Dear Mr. Patton:
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). 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 requlations affecting your device can be found in the Code of Federal Requlations, 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), piease 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
2
Page of
510 (k) NUMBER (IF KNOWN) : K991963
Patton Speculum™ DEVICE NAME:
INDICATIONS FOR USE:
The Patton Speculum™ is intended for use to retract the vagina in diagnostic and therapeutic obstetrical and gynecological procedures.
(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)
- ﻣ
OR
Over-The-Counter-Use (Optional Format 1-2
Vinit h. bejgm
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number