(305 days)
Not Found
No
The device description and intended use describe a mechanical suction device for tissue sampling, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to obtain a sample of endometrial tissue for diagnostic purposes, not to treat a disease or condition.
Yes
The device is used to obtain a sample of differential endometrial tissue, which is a common procedure for diagnosing conditions affecting the endometrium.
No
The device description clearly describes physical hardware components (endometrial suction device, syringe, curette, piston) used to obtain a tissue sample. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain a sample of differential endometrial tissue" from the uterus by scraping and suction. This is a procedure to collect a biological sample from the body.
- Device Description: The device is described as an "endometrial suction device" or "endometrial suction curette" used to obtain a tissue sample.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) to collect the specimen.
The device is a tool for collecting a sample, which would then likely be sent to a laboratory for in vitro diagnostic testing (e.g., histological examination). The device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
This device is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy or for menstrual extraction
Product codes
85 HHK
Device Description
The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only.
The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
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)
Not Found
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
§ 884.1175 Endometrial suction curette and accessories.
(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).
0
510(k) Summary As Required by 21 section 807.92 ( c )
APR 0 8 2003
1-Submitter Name: Mansour Consulting LLC
-
1308 Morningside Park Dr 2-Address:
Alpharetta, GA 30022 USA -
3-Phone: (678) 908- 8180
(425) 795- 9341 4-Fax:
5-Contact Person: Jay Mansour
6-Date summary prepared: May 28th, 2002
7-Device Trade or Proprietary Name: Marina Ampler Sampler (with and without syringe)
8-Device Common or usual name: Endometrial Suction Curette
-
Curette, Suction, Endometrial 9-Device Classification Name:
10-Substantial Equivalency is claimed against the following device: -
Curelle from Bioteque Corporation, 510k #K915491 .
11-Description of the Device:
The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only.
The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.
12-Intended use of the device:
This device is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy or for menstrual extraction
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
1
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.
7
| FDA file reference number | 510k 915491 | |
|---|---|---|
| Attachments inside notification | ||
| submission file | Appendix 1 and 2 | |
| TECHNOLOGICAL | ||
| CHARACTERISTICS | Comparison result | |
| With Syringe | Without Syringe | |
| Indications for use | Identical | |
| Target population | Identical | |
| Design | Identical | Similar |
| Materials | Identical | |
| Performance | Identical | |
| Sterility | Identical (Ethylene Oxide) | |
| Biocompatibility | Identical | |
| Mechanical safety | Identical | |
| Chemical safety | Identical | |
| Anatomical sites | Identical | |
| Human factors | Identical | |
| Energy used and/or delivered | Identical | |
| Compatibility with environment | ||
| and other devices | Identical | Similar |
| Where used | Identical | |
| Standards met | Identical | |
| Electrical safety | Identical (not applicable) | |
| Thermal safety | Identical (not applicable) | |
| Radiation safety | Identical (not applicable) |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Marina Medical Instruments, Inc. % Mr. Jay Mansour Regulatory Consultant Mansour Consulting, LLC 1308 Morningside Park Dr. ALPHARETTA GA 30022
Re: K021876
APR 0 8 2003
Trade/Device Name: MAS With or Without Syringe Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial suction curette and accessories Regulatory Class: II Product Code: 85 HHK
Dated: January 28, 2003 Received: January 30, 2003
Dear Mr. Mansour:
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. 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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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 C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
KOZI876 510(k) Number (if known): CUTH SYRINGE & all THOUT Device Name: Indications For Use:
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdomina d Radiological Devices
Prescription Use
(Per 21 CFR 801.109) √
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Over-The-Counter Use
(Optional Format 1-2-96