(163 days)
Not Found
No
The device description focuses on the mechanical function of obtaining a sample and does not mention any computational analysis or processing of data using AI/ML. The performance studies are also focused on physical properties and biocompatibility.
No
This device is for obtaining endometrial tissue samples for diagnostic purposes (cytological and histological analysis) and is not intended to treat a disease or condition.
Yes.
The device is used to obtain samples (endometrial cytological and histological samples) for diagnostic purposes.
No
The device description clearly details a physical, single-use, sterile device made of various materials (polydimethylsiloxane, polyethylene, stainless steel, etc.) designed for obtaining physical samples. It does not mention any software components.
Based on the provided information, the Utepreva Endometrial Sampler (UP01) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device's intended use is to obtain samples (cytological and histological). It is a tool for sample collection.
- Device Description: The description details the mechanical function of the device for collecting tissue and fluid. It does not describe any analytical or diagnostic function performed by the device itself.
- Lack of Diagnostic Function: The device collects the sample, which is then intended to be immersed in a preservative solution and used by a pathology lab. The diagnostic analysis is performed on the sample by the lab, not by the Utepreva Endometrial Sampler.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the device (biocompatibility, strength, retention, etc.), not on its ability to perform a diagnostic test or provide diagnostic information.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Utepreva Endometrial Sampler is a sample collection device, which is a pre-analytical step in the diagnostic process, but it is not the diagnostic device itself.
N/A
Intended Use / Indications for Use
The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.
Product codes
HFE
Device Description
The Utepreva Endometrial Sampler (UP01) is a single-use, sterile device designed to obtain endometrial cytological and histological samples. The device is an Rx device that functions as follows: The Utepreva Endometrial Sampler is gently inserted though the cervix into the uterus. The skirt (guard) will reach the cervix indicating to the clinician to stop inserting the device. The brush is then extended by pushing the handle until resistance is felt when the tip meets the fundus of the uterus. The sponge on the tip is intended to minimize the risk of piercing of the fundus by the tip of the brush and enables additional tissue sampling by absorption of the fluid and the cells from the uterus. The Utepreva Endometrial Sampler is rotated in a clockwise or counterclockwise manner for four or five 360° rotations. Upon completion of the rotations, the handle is pulled back so that the brush and tip are withdrawn into the outer sheath. The suction created by the plunger located inside of the sheath provides aspiration of the cells and prevents loss of the sample from the brush, sponge and any fluid that was aspirated can then be immersed into the preservative solution to be used by the pathology lab.
The device materials consist of polydimethylsiloxane, high density polyethylene, cyanoacrylate adhesive, Loctite, Permabond polyolefin primer, stainless steel, Nylon, polycarbonate, and polypropylene. The device is packaged in a Tyvek® pouch. One pouch is then packaged in a unit box. Fifteen unit boxes are packaged within a single master box to create the final shipped product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endometrial
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)
Non-clinical performance testing was conducted to verify the Utepreva Endometrial Sampler performance. The following performance data was provided in support of the substantial equivalence determination:
- Biocompatibility: Pass
- Cytotoxicity Testing (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Visual & Dimensional Inspection: Pass
- Tensile Strength: Pass
- Torque: Pass
- Bristle Retention: Pass
- Fluid Retention: Pass
- Fluid Transfer: Pass
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
§ 884.1100 Endometrial brush.
(a)
Identification. An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(2) Labeling:
(i) Indication: Only to evaluate the endometrium, and
(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
(3) Design and testing:
(i) The sampling component is covered within the vagina, and
(ii) For adherence of the bristles and brush head.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2024
Utepreva LLC % Melissa Paffenroth Senior Regulatory Consultant MEDIcept, LLC. 200 Homer Avenue Ashland, Massachusetts 01721
Re: K240595
Trade/Device Name: Utepreva Endometrial Sampler (UP01) Regulation Number: 21 CFR 884.1100 Regulation Name: Endometrial Brush Regulatory Class: II Product Code: HFE Dated: March 4, 2024 Received: July 1, 2024
Dear Melissa Paffenroth:
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. Drue, and Cosmetic 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 available at https://www.accessdata.fda.gov/scripts/cdth/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Ouality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/trainingand-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory- assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240595
Device Name
Utepreva Endometrial Sampler (UP01)
Indications for Use (Describe)
The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.
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 Utepreva, LLC Utepreva Endometrial Sampler (UP01)
I. SUBMITTER
| 510(k) Holder: | Utepreva, LLC
100 Jericho Quadrangle
Suite 333
Jericho, NY 11753 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Melissa Paffenroth, PhD, RAC-Devices
Senior Consultant, Regulatory
MEDIcept, Inc.
Tel: (617) 512-9943
Email: mpaffenroth@medicept.com |
Date Prepared: March 4, 2024
II. DEVICE
| Name of Device: | Utepreva Endometrial Sampler (UP01) |
|---|---|
| Common Name: | Endometrial brush |
| Classification Name: | Brush, Endometrial |
| Regulation Number: | 21 CFR 884.1100 |
| Regulatory Class: | Class II |
| Product Code: | HFE |
III. PREDICATE DEVICE
K170603, Tao BrushTM I.U.M.C Endometrial
The predicate device identified above has not been subject to design-related recalls.
IV. DEVICE DESCRIPTION
The Utepreva Endometrial Sampler (UP01) is a single-use, sterile device designed to obtain endometrial cytological and histological samples. The device is an Rx device that functions as follows: The Utepreva Endometrial Sampler is gently inserted though the cervix into the uterus. The skirt (guard) will reach the cervix indicating to the clinician to stop inserting the device. The brush is then extended by pushing the handle until resistance is felt when the tip meets the fundus of the uterus. The sponge on the tip is intended to minimize the risk of piercing of the fundus by the tip of the brush and enables additional tissue sampling by absorption of the fluid and the cells from the uterus. The Utepreva Endometrial Sampler is rotated in a clockwise or counterclockwise manner for four or five 360° rotations. Upon completion of the rotations, the handle is pulled back so that the brush and tip are withdrawn into the outer sheath. The suction
4
created by the plunger located inside of the sheath provides aspiration of the cells and prevents loss of the sample from the brush, sponge and any fluid that was aspirated can then be immersed into the preservative solution to be used by the pathology lab.
The device materials consist of polydimethylsiloxane, high density polyethylene, cyanoacrylate adhesive, Loctite, Permabond polyolefin primer, stainless steel, Nylon, polycarbonate, and polypropylene. The device is packaged in a Tyvek® pouch. One pouch is then packaged in a unit box. Fifteen unit boxes are packaged within a single master box to create the final shipped product.
V. INDICATIONS FOR USE
The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
In accordance with the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued July 28, 2014, the comparison between the predicate and the subject devices is shown to be substantially equivalent by comparing the indications for use, principles of operation, technological characteristics, and performance testing similarities and differences (Table 1). The technological characteristic differences rationale demonstrates that the subject device is safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness than the predicate device.
| Characteristic | Subject Device
Utepreva Endometrial
Sampler (UP01)
(K240595) | Predicate Device
Tao Brush™ I.U.M.C.
Endometrial Sampler
(K170603) | Comparison |
|------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------|------------|
| Regulatory Class | Class II | Class II | Same |
| Regulatory Number | 884.1100 | 884.1100 | Same |
| Regulation Name | Endometrial Brush | Endometrial Brush | Same |
| Product Code | HFE | HFE | Same |
| Manufacturer | Utepreva LLC | Cook Incorporated | - |
| Rx/OTC | Rx | Rx | Same |
| Sterile | Yes | Yes | Same |
| Sterilization | EtO | EtO | Same |
| Shelf-Life | 3 months | 3 years | Different |
| Insertion Depth
Indicator | Skirt (Guard) on Sheath | Black Ink Mark on Sheath | Different |
| Dimensions | | | |
| Working Length | 26.8 cm | 26.9 cm | Similar |
| Ball Tip | 10.2 Fr | 9.5 Fr | Similar |
Table 1. Comparison Table for Subject Device Utepreva Endometrial Sampler and Predicate Device Tao Brush™ I.U.M.C. Endometrial Sampler
5
| Characteristic | Subject Device
Utepreva Endometrial
Sampler (UP01)
(K240595) | Predicate Device
Tao Brush™ I.U.M.C.
Endometrial Sampler
(K170603) | Comparison |
|----------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------|------------|
| Sheath OD | 11.43 Fr | 9.3 Fr | Similar |
| Outer Sheath Length | 22.9 cm | 21.5 cm | Similar |
| Brush Length | 3.2 cm | 3.5 cm | Similar |
| Brush Diameter | 3 mm | 6 mm | Different |
| Insertion Depth
Indicator Distance from
Distal Tip | 6.58 cm | 7 cm | Similar |
| Materials | | | |
| Insertion Depth
Indicator | Skirt: Polycarbonate,
acrylic adhesive | Black ink mark on sheath | Different |
| Wire Core | Stainless steel | Stainless steel | Same |
| Plunger | Polydimethylsiloxane | NA | - |
| Silicone Fluid | Polydimethylsiloxane | NA | - |
| Brush Bristles | Nylon | Nylon | Same |
| Backstop | Nylon 11 | NA | - |
| Ball Tip | Polyurethane,
Polypropylene | Acrylonitrile butadiene
styrene (ABS) | Different |
PERFORMANCE DATA VII.
Non-clinical performance testing was conducted to verify the Utepreva Endometrial Sampler performance. The following performance data was provided in support of the substantial equivalence determination (Table 2).
Table 2. Non-Clinical Performance Testing
| Test | Conclusion |
|---|---|
| Biocompatibility | Pass |
| Cytotoxicity Testing (ISO 10993-5:2009) Sensitization (ISO 10993-10:2010) Vaginal Irritation (ISO 10993-10:2010) | |
| Visual & Dimensional Inspection | Pass |
| Tensile Strength | Pass |
| Torque | Pass |
| Bristle Retention | Pass |
| Fluid Retention | Pass |
| Fluid Transfer | Pass |
VIII. CONCLUSIONS
The information provided and summarized in the substantial equivalence table and performance testing results demonstrate that the Utepreva Endometrial Sampler is as safe and effective as the predicate device and support a determination of substantial equivalence.