(218 days)
To obtain endocervical cells for Pap smear cytology test
The Puritan Histobrush consists of nylon bristles secured by stainless steel to a plastic handle. The device is used to obtain endocervical samples for Pap smear cytology. The device is for single use only and is non-sterile.
The provided text is a 510(k) summary for a medical device called "Histobrush Model 2188," a cervical cytology brush. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, rather than proving performance against specific acceptance criteria through a standalone clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and human expert involvement is not applicable or not provided in this document.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" in the way a performance claim for an AI/diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. The "reported device performance" is essentially the equivalence shown through these tests and comparisons.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Non-Clinical Test Results) |
|---|---|
| Biocompatibility | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Tensile strength of brush fibers | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Force to remove fibers from wire | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Force to remove wire from handle | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Note: The document explicitly states: "The results of the testing demonstrate substantial equivalence to predicate cervical cytology brushes." |
2. Sample size used for the test set and the data provenance
For the non-clinical tests (biocompatibility, tensile strength, fiber removal force, wire removal force), the sample sizes are not specified in this document.
The data provenance is not specified regarding country of origin or whether it's retrospective/prospective, as no clinical study on human subjects is described. The tests are non-clinical (laboratory-based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This document describes non-clinical engineering and materials testing, not a study requiring human experts to establish ground truth for a diagnostic outcome.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. As there's no diagnostic test set or human expert review, there's no adjudication method described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This device is a manual medical instrument (cervical cytology brush), not an AI or imaging diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would be the established engineering and material standards for the specific tests conducted (e.g., specific force thresholds for tensile strength, biocompatibility standards). These are implied standards relevant to the predicate devices, as the comparison is one of substantial equivalence. No pathology or outcomes data is referenced.
8. The sample size for the training set
Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As above, no training set for an algorithm is relevant here.
In summary:
This 510(k) submission for the Histobrush Model 2188 demonstrates substantial equivalence by comparing its technological characteristics and non-clinical test results (biocompatibility, mechanical strength) to previously cleared predicate devices. It does not involve clinical studies with human participants, AI algorithms, or the establishment of diagnostic ground truth by experts from patient data. The "study" referenced is a series of non-clinical, laboratory-based tests to ensure the new device performs similarly and safely to existing products.
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11681 JAN 1 9 2012
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
| 1. | Submitted by: | Puritan Medical Products Co LLC |
|---|---|---|
| Contact person: | William M. Young | |
| Date of preparation: | December 19, 2011 | |
| 2. | Trade Name of Device: | Histobrush Model 2188 |
| Common name: | Cervical cytology brush | |
| Classification name: | Cytological endocervical brush | |
| 3. | Predicate Devices: | Histobrush, Spectrum Companies, K874604Cell Collecting Brush, Anderson Winn, K924908 |
| 4. | Device description: | The Puritan Histobrush consists of nylon bristlessecured by stainless steel to a plastic handle. The device is used toobtain endocervical samples for Pap smear cytology. The device is for |
- Indications for use: To obtain endocervical cells for Pap smear cytology test. 5.
-
- The Puritan Histobrush is used to obtain cervical samples for Intended use: transfer to a microscope slide or specimen preservation vial.
| Histobrush ® (Model 2188) | Predicate device | |
|---|---|---|
| Tip material | Nylon | Nylon |
| Tip length (inches) | 0.750 | 0.600 |
| Tip diametermaximum/minimum(inches) | 0.250/0.200 | 0.280/0.120 |
| Twisted wire | Stainless steel 304 | Stainless steel 304 |
| Handle material | Polystyrene | Polystyrene |
| Overall length (inches) | 8 | 6 |
- Comparison of technological characteristics to predicates: 7.
single use only and is non-sterile.
Discussion of non-clinical tests 8.
Non-clinical testing included: biocompatibility, tensile strength of brush fibers, force to remove fibers from wire, and force to remove wire from handle. The results of the testing demonstrate substantial equivalence to predicate cervical cytology brushes.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. William Young Vice President, Quality Systems Puritan Medical Products Co LLC 31 School Street GUILFORD MA 04443
JAN 1 9 2012
KI11681 Re: Trade Name: Histobrush® (Model 2188) Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HI-IT Dated: December 19, 2011 Received: December 21, 2011
Dear Mr. Young:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 associated in the encreations 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 r ou may, alcreve, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 001); with an 170 ); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Tucker
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): __K111681
Device Name: Histobrush® Model 2188
Indications for Use:
To obtain endocervical cells for Pap smear cytology test
Prescription Use _ ﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Helend Seeman
sion Signve, Gastro-Renal, and
Page 1 of 1 __
§ 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.