(268 days)
Not Found
No
The device description and performance studies focus on the physical collection and transfer of samples, with no mention of AI or ML technologies.
No
The device is described as a collection device for diagnostic purposes (ThinPrep Pap test), not for treating a condition or disease.
No
The device is a collection device for specimens used in diagnostic tests, not a diagnostic device itself.
No
The device description explicitly states it is a "disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic," indicating it is a physical hardware device.
Based on the provided text, the ExCellerator Cervical Collection Device is not an IVD (In Vitro Diagnostic) itself.
Here's why:
- Intended Use: The device is described as a "cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test." It's a tool for collecting the sample, not for performing the diagnostic test itself.
- Device Description: It's described as a "non-sterile, single use, disposable cervical sampling device (spatula)." This reinforces its role as a collection tool.
- Relationship to IVD: The text explicitly states the device "must be used with an IVD labeled endocervical brush" and "aids in more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing." This indicates it's a component or accessory used with an IVD (the endocervical brush and the ThinPrep system), but it's not the diagnostic test itself.
- Predicate Device: The predicate device is a "Pap Perfect Plastic Spatula," which is also a collection tool, not an IVD.
In summary, the ExCellerator Cervical Collection Device is a sample collection device used in conjunction with an IVD (the ThinPrep Pap test system and the endocervical brush), but it does not perform the diagnostic analysis itself.
N/A
Intended Use / Indications for Use
The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.
Product codes (comma separated list FDA assigned to the subject device)
HHT
Device Description
The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure.
Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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)
Testing - Biocompatibility:
- Cytotoxicity (MEM Elution Cytotoxicity Assay (ISO)): Non-Cytotoxic, Passed
- Irritation (Vaginal Mucosal Irritation Test (ISO)): Non-Irritant, Passed
- Sensitivity (Guinea Pig Maximization Test (ISO)): Non-sensitizer, Passed
Testing - Performance - Non-Clinical (Mechanical tests):
- Static Bend (Static Cantilever Bend): 7 years
Testing - Dimensional Measures:
All specified dimensional measurements (Length, Width - Rail, Width - Paddle End, Width - Head End, Height - Rail, Height - Paddle End, Height – Head End, Hole Length, Hole Width, Hole to Proximal End, Hole to Distal End) were Compliant with Acceptance Criteria of
§ 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
April 25, 2019
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ExCell Company LLC Jim Snyder President 1540 West Main Street Carmel, IN 46032
Re: K182049
Trade/Device Name: ExCellerator Cervical Collection Device Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: Class II Product Code: HHT Dated: July 27, 2018 Received: July 31, 2018
Dear Mr. Snyder:
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 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yun-fu Hu -S
for Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182049
Device Name ExCellerator Cervical Collection Device
Indications for Use (Describe)
The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR [807.92(a)(1)]
| Date Prepared: | April 23, 2019 |
|---|---|
| 510(k) Owner: | ExCell Company LLC |
| 1540 W. Main Street | |
| Carmel, IN 46032 | |
| 317.358.9610 p | |
| snyper7x7@gmail.com | |
| Contact: | Jim Snyder – President |
| Trade Name: | ExCellerator™ |
| Common Name: | Cervical Collection Device (spatula) |
| Classification Name: | Collector, Cervical Cytological (Obstetric-gynecologic specialized manual instrument) |
| Device Classification: | Class II |
| Product Code: | HHT |
| Predicate Device: | Pap Perfect Plastic Spatula (K861389) |
Device Description:
The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure.
Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.
Use Description:
- The ectocervix is sampled using the ExCellerator cervical cytological spatula. The ● endocervix is sampled using the IVD labeled endocervical brush.
- The clinician uses both devices as she/he would ordinarily in the manual application of . the devices to the ectocervix and endocervix.
- Cells are transferred from the spatula and endocervical brush into liquid preservative ● (ThinPrep PreservCyt) in accordance with standard protocol.
- Removal of the sample from the endocervical brush is aided by the ExCellerator by . utilizing the hole in the device to tease the sample off the brush according to the package insert.
Intended Use:
The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush), to the PreservCyt solution for the ThinPrep Pap testing.
The ExCellerator device must be used with an IVD labeled endocervical brush.
4
Indications for Use See Intended Use above.
Technological Characteristics:
The ExCellerator™ cervical cytological spatula is a standard device in terms of overall design and use, and satisfies the definition of a cytological cervical spatula, which is: "A cytological cervical spatula is a blunt instrument used to scrape and remove cytological materials from the surface of the cervix or vagina." – 21 CFR 884.4530 (a)(13).
The ExCellerator™ cervical cytological spatula is different in one (1) respect. It has an oblong opening "Hole" ~0.250 x 0.130-in. in size, located ~6.19-in. on center from the spatula paddle end, and slightly less than 1' from the head end, which places it between the raised support ribs of the shaft. Its location facilitates the user's placing the tip of the brush into the opening while the dog bone end is immersed in liquid preservative. The hole does not impact the way the spatula is used to sample the ectocervix.
New technological characteristic 0
The hole in the exCellerator™ can be considered a new technological characteristic. Its use minimizes inter-operator variability among collectors in removing the cytological sample from the endocervical brush. It does not affect how either the spatula or endocervical brush are used to remove cells from the ectocervix and endocervix, how cells are transferred from either device into liquid preservative, or how and what testing is performed on the sample.
Testing - Biocompatibility:
Biocompatibility tests were conducted to ensure safety and effectiveness of the device:
| Assessment | Test | Criteria | Result |
|---|---|---|---|
| Cytotoxicity | MEM Elution Cytotoxicity Assay | ||
| (ISO) | Non-Cytotoxic | Passed | |
| Irritation | Vaginal Mucosal Irritation Test | ||
| (ISO) | Non-Irritant | Passed | |
| Sensitivity | Guinea Pig Maximization Test | ||
| (ISO) | Non-sensitizer | Passed |
Summary Table: Biocompatibility Assessments
Testing - Performance - Non-Clinical:
Mechanical tests were conducted to demonstrate substantial equivalence of the device to the predicate in terms of safety and effectiveness.
5
Summary Table: Structural Assessments
| Assessment | Test Performed | Acceptance
Criteria | Control Mode | Group | Result |
|----------------|---------------------------|------------------------|-------------------------|-------|--------|
| Static Bend | Static Cantilever
Bend | 7 years
Testing - Dimensional Measures
Dimensional Assessments were made to ensure production consistency of the device.
| Summary Table: Dimensional Assessments | |
|---|---|
| ---------------------------------------- | -- |
| Measurement (inches) | Acceptance Criteria | Result |
|---|---|---|
| Length |