(39 days)
Not Found
Not Found
No
The summary describes a physical needle guide accessory for ultrasound transducers and makes no mention of software, algorithms, or AI/ML capabilities.
No
The device is used to attach needles to ultrasound transducers for procedures like oocyte harvesting and tissue biopsy, making it an accessory for guiding therapeutic or diagnostic procedures rather than a therapeutic device itself.
No
This device is a needle guide, used for attaching needles to ultrasound transducers for procedures like oocyte harvesting and tissue biopsy. It facilitates a medical procedure rather than providing diagnostic information itself.
No
The device description explicitly states it is a "Re-usable ultrasound needle guide" and mentions "attachment of needles to specified ultrasound transducers," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Ultrasound Needle Guides are for the "attachment of needles to specified ultrasound transducers" for use in "ultrasound guided oocyte harvesting and tissue biopsy." This describes a device used during a medical procedure performed on a patient, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Ultrasound Needle Guides are for the attachment of needles to specified ultrasound transducers. For use in ultrasound guided oocyte harvesting and tissue biopsy.
Product codes (comma separated list FDA assigned to the subject device)
85 MQE and 90 IYO
Device Description
Re-usable ultrasound needle guides have been in use for over 20 years. The device is safe and effective for the application for which it is intended. More recently concerns about cross infection and patient pain have produced some single use versions being in use for the past 3 years, without any known incident in the UK.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
0
Rocket Medical plc - 510(k) Notification Embryon® Ultrasound Needle Guide AUG - 8 2003
KD32015
Summary of Safety and Effectiveness
This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA
Re-usable ultrasound needle guides have been in use for over 20 years. The device is safe and effective for the application for which it is intended. More recently concerns about cross infection and patient pain have produced some single use versions being in use for the past 3 years, without any known incident in the UK.
Rocket Medical plc continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
20/6/03
Date
Date
T. Cordentia
Signed by Tracy Charlton Regulatory Affairs Manager Rocket Medical plc Wear Industrial Estate, Washington Tyne & Wear, England. NE38 9BZ
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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 features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2003
Ms. Tracy Charlton Regulatory Affairs Manager Rocket Medical PLC Wear Industrial Estate District 6, Washington Tyne & Wear, NE38 9BZ UNITED KINGDOM
Re: K032015
Trade/Device Name: Embryon® Ultrasound Needle Guide Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted reproduction needles Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed imaging system Regulatory Class: II Product Code: 85 MQE and 90 IYO Dated: June 20, 2003 Received: July 21, 2003
Dear Ms. Charlton:
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.
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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
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Rocket Medical plc - 510(k) Notification Embryon® Ultrasound Needle Guide
Indications for Use
Ultrasound Needle Guides are for the attachment of needles to specified ultrasound transducers.
For use in ultrasound guided oocyte harvesting and tissue biopsy.
T. Chauta
Signed T.Charlton Regulatory Affairs Manager
Rocket Medical Plc 20th June 2003
Prescription Use
(Per 21 CFR 801.109)
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device 510(k) Number