(42 days)
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No
The summary describes a physical device for sample collection and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as being for collecting cell samples for diagnosis, not for treating a condition.
No
This device is for collecting samples for diagnostic evaluation, not for performing the diagnostic evaluation itself.
No
The device description clearly states it is a "one-time use device for collecting vaginal and cervical cell samples," indicating it is a physical instrument, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. While this device collects specimens from the human body (vaginal and cervical cells), it is the collection device itself, not the diagnostic test performed on the collected sample.
- The intended use describes the collection of samples for subsequent evaluation and diagnosis. The diagnostic process (cytological evaluation and infection diagnosis) happens after the sample is collected, likely in a laboratory setting using other IVD devices or methods.
- The device description focuses on the physical characteristics and performance of the collection brush. It doesn't describe any reagents, assays, or analytical processes that would be characteristic of an IVD.
In summary, the Detect™ Cytology Brush II is a specimen collection device, which is a different category of medical device than an IVD. The IVD would be the test performed on the sample collected by this brush.
N/A
Intended Use / Indications for Use
The Detect™ Cytology Brush II is a one-time use device for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell sampling or for use on pregnant patients.
Product codes
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Device Description
The Detect™ Cytology Brush II is a one-time use device for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell sampling or for use on pregnant patients. The materials of construction have undergone biocompatibility testing and met the requirements of the tests. Testing was also conducted to characterize the performance and integrity of the device. Results were comparable to those obtained when similarly testing a predicate device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vaginal and cervical
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) Premarket Notification Detect Cytology Brush II Cook OB/GYN
MAR 1 4 1996
K 960469
9
J. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Tammy Bacon Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 January 31, 1996
Device
Trade Name: Common/Usual Name: Proposed Classification Name:
Predicate Devices:
Detect™ Cytology Brush II Biopsy Brush, Cell Collector Obstetrical-Gynecologic Specialized Manual Instrument
The Detect™ Cytology Brush II is a disposable gynecologic manual instrument for collecting vaginal and cervical cell samples similar to predicate cell collector brushes in terms of indications for use and technology.
Device Description:
The Detect™ Cytology Brush II is a one-time use device for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell sampling or for use on pregnant patients. The materials of construction have undergone biocompatibility testing and met the requirements of the tests. Testing was also conducted to characterize the performance and integrity of the device. Results were comparable to those obtained when similarly testing a predicate device.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing procedures similar to devices currently marketed and distributed by Cook OB/GYN, This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalency.