(242 days)
The InPath™ e² Collector™ is intended for the collection of cervical cytology specimens for Pap test analysis. The InPath™ e² Collector™ should not be used after the first 10 weeks of gestation in pregnant patients.
The InPath e2 Collector (e2 Collector) is a multi-component assembly for the collection and transport of exfoliated cervical epithelial cells. The major e2 Collector components are a balloon that provides the conformal surface upon which the cells are collected, and a handle that provides a means of manipulating and expanding the balloon during the sampling process. The balloon consists of a medical grade silicone and colorant. The tip of the balloon is designed to be expanded during sampling by at least a factor of two over its resting diameter to accommodate the range of endocervical canal diameters commonly encountered in clinical practice. The body of the balloon is sized to collect cells from an area of the ectocervix, centered on the cervical canal, which is approximately 23 mm-diameter. The balloon tip measures about 3 mm in diameter, and 12 mm in length when uninflated, and it can be introduced without difficulty to the endocervix.
The provided text describes the "InPath™ e2 Collector™" and its substantial equivalence to predicate devices, but it does not contain detailed information about specific acceptance criteria or a dedicated study that proves the device meets such criteria.
The text focuses on the device description, intended use, and a conclusion of substantial equivalence based on "essentially identical indications for use, substantially equivalent principles of operation, and clinical trial results that demonstrate performance equal to, or better than, the predicate devices." However, it does not elaborate on these "clinical trial results" or define the acceptance criteria used.
Therefore, many of the requested items cannot be definitively answered from the provided text.
Here is a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria or detailed reported device performance metrics. It only states: "clinical trial results that demonstrate performance equal to, or better than, the predicate devices." Without the actual performance metrics or defined criteria, this table cannot be populated.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided text.
- Data provenance (country of origin, retrospective/prospective): Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in the provided text.
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:
- MRMC study: Not explicitly mentioned. Given the device is a collection tool and not an AI-assisted diagnostic, an MRMC study with AI assistance is unlikely to be relevant to this specific device. The device is for collection of samples for Pap test analysis, not for the analysis itself.
- Effect size of human reader improvement with AI: Not applicable, as this is a collection device, not an AI-driven diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical collection tool, not an algorithm. Performance would inherently involve human use (collecting the sample).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not specified. The clinical trial results are broad and not detailed. For a collection device for cervical cytology, ground truth would typically relate to the quality and adequacy of the collected sample for subsequent Pap test analysis, which can involve expert cytopathologist review or correlation with follow-up pathology. However, this is not stated.
8. The sample size for the training set:
Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
Summary of available information:
The document primarily acts as a 510(k) summary, establishing substantial equivalence to predicate devices (Digene Cervical Brush and Rovers Cervex-Brush) based on:
- Identical indications for use.
- Substantially equivalent principles of operation.
- "Clinical trial results that demonstrate performance equal to, or better than, the predicate devices."
However, the specific details of these "clinical trial results," the acceptance criteria they met, and the methodologies used (sample sizes, ground truth establishment, expert involvement, etc.) are not present in the provided text. This document is a high-level summary for regulatory clearance, not a detailed study report.
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K013258
Page 1 of 2
ATTACHMENT 3 Revised 510(K) SUMMARY
Submitter:
Molecular Diagnostics, Inc.
Contact Person:
Julie Hoff, Pharm.D. 414 North Orleans, Suite 510 Chicago, IL 60610 Phone: 312-222-9550 Fax: 312-222-9580
Date Prepared:
May 28, 2002
Trade Name:
Product Code:
InPath™ e2 Collector™
Classification Name: and Number:
Class II, 21 CFR 884.4530
HHT
(K930955).
Predicate Device(s):
Device Description:
The InPath e2 Collector (e2 Collector) is a multi-component assembly for the collection and transport of exfoliated cervical epithelial cells. The major e2 Collector components are a balloon that provides the conformal surface upon which the cells are collected, and a handle that provides a means of manipulating and expanding the balloon during the sampling process.
The Molecular Diagnostics, Inc. InPath™ e2 Collector™
equivalent to the Digene Cervical Brush from the Digene Corporation (K971586) and the Rovers Cervex-Brush
cervical cytology collection device is substantially
The balloon consists of a medical grade silicone and colorant. The tip of the balloon is designed to be expanded during sampling by at least a factor of two over its resting diameter to accommodate the range of endocervical canal diameters commonly encountered in clinical practice. The body of the balloon is sized to collect cells from an area of the ectocervix, centered on the cervical canal, which is approximately 23 mm-diameter. The balloon tip measures about 3 mm in diameter, and 12 mm in length when uninflated, and it can be introduced without difficulty to the endocervix.
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K013258
Page 2 of 2
Intended Use:
Functional and Safety Testing:
Conclusion:
The InPath™ e2 Collector™ is intended for the collection of cervical cytology specimens for Pap test analysis. The InPath™ e2 Collector™ should not be used after the first 10 weeks of gestation in pregnant patients.
Representative samples of InPath™ e2 Collectors underwent design testing to demonstrate substantially equivalent functional characteristics. In addition, manufacturing process testing is done to assure that the devices produced meet design requirements.
The InPath™ e2 Collector™ manufactured by Molecular Diagnostics, Inc. is substantially equivalent to the Digene Cervical Brush from the Digene Corporation (K971586) and the Rovers Cervex-Brush (K930955). This conclusion is based upon the fact that these devices have essentially identical indications for use, substantially equivalent principles of operation, and clinical trial results that demonstrate performance equal to, or better than, the predicate devices.
Page 2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, possibly representing care or protection. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 31 2002
Molecular Diagnostics, Inc. % Ms. Ann Quinlan-Smith Consultant to Molecular Diagnostics Alquest, Incorporated 4050 Olson Memorial Hway., Suite 350 MINNEAPOLIS MN 55422
Re: K013258
Trade/Device Name: InPath™ e2 Collector Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: 85 HHT
Dated: March 29, 2002 Received: March 29, 2002
Dear Ms. Quinlan-Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed four becaused in added is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated 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 r ou mayy aroney interes 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 (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.
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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 noutication. The I Dri miding of bassion 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 IT you desire specific advice for your ac rise on our 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 Additionally, for questions on any pease note the regulation entitled, "Misbranding Offically of Comphilation" (21 CFR Part 807.97). Other general information on by releve to promative nearcharday be obtained from the Division of Small Manufacturers, your responsional 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 Crogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Page
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K013258
Device Name: The InPath™ e2 Collector™
Indications for Use:
The InPath™ e² Collector™ is intended for the collection of cervical cytology specimens The InPath™E Collector™ Is michdod for the conceasing hot be used after the first 10 weeks of gestation in pregnant patients.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Daniel A. Ingram
Division Sign-Off Division of Renn 510(k) Nu
§ 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.