(253 days)
No
The device description focuses on physical characteristics and materials of glass pipettes used for manual aspiration, with no mention of software, algorithms, or automated analysis.
No
The devices are used for sample collection (biopsy) for genetic diagnosis, not for treating or curing a disease or condition. They are diagnostic tools for preimplantation genetic diagnosis.
No
These devices are tools used for the removal of cells (blastomeres or polar bodies) for the purpose of preimplantation genetic diagnosis. They are not the diagnostic device themselves; rather, they enable the collection of samples that will then be sent for genetic diagnosis.
No
The device description explicitly states that the devices are "very fine glass pipettes" and are "manufactured entirely from borosilicate glass," indicating they are physical hardware devices, not software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Blastomere Biopsy Pipettes and Polar Body Biopsy Pipettes are tools used to obtain a sample (blastomeres or polar bodies) from an embryo or oocyte. They are not used to perform a test on that sample to provide diagnostic information.
- Intended Use: The intended use clearly states that the removal of the cells is done in order to perform preimplantation genetic diagnosis. The diagnosis itself is performed on the genetic material in the biopsied cells, likely using a separate IVD device or process.
- Device Description: The description focuses on the physical characteristics of the pipettes (material, size, shape) and their function in the biopsy process. It does not describe any analytical or diagnostic capabilities.
In summary, these pipettes are instruments used in a procedure (biopsy) that is a step in a larger process (preimplantation genetic diagnosis). They are not the devices that perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
Product codes (comma separated list FDA assigned to the subject device)
MQH
Device Description
The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight.
The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences.
These devices are intended for one-time use and will be marked sterile.
These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
These devices are to be used by professionals trained in assisted reproduction technologies (ART).
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.
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.
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
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
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Premarket Notification - Sunlight Medical, Inc - Biopsy Pipettes
510(k) SUMMARY
510(k) Number (if known): K092554
Submitter's Name: Sunlight Medical, Inc.
APR 3 0 2010
10f3
Address: 12443 San Jose Blvd, Suite 602, Jacksonville, FL 32223
Telephone #: (904) 866-7978
FAX #: (904) 886 2900
Contact person: Dunsong Yang
Date summary prepared: August 12, 2009, revised January 5, 2010
Device name:
Common / usual name: Preimplantation Genetic Diagnosis Pipettes (Biopsy Pipettes)
| Proprietary names: | Blastomere Biopsy Pipettes
Polar Body Biopsy Pipettes |
|----------------------|----------------------------------------------------------|
| Classification name: | Class II Assisted reproduction microtools
85MQH |
| CER Reference: | 884.6130 |
Predicate Devices:
The Blastomere Biopsy Pipettes and Polar Body Biopsy Pipettes to be manufactured by Sunlight Medical, Inc. are substantially equivalent to the Blastomere Biopsy Micropipets and Polar Body Micropipets (510K number: K012811) manufactured by Humagen Fertility Diagnostics, Inc., 2345 Hunter's Way, Charlottesville, VA 22901-7928. Specially, the Biopsy Pipettes are similar to other pipettes manufactured by Sunlight Medical and approved under K072600. The Biopsy Pipettes vary only by size and shape of the tip as determined by their usage as do the pipettes already approved. The material, manufacture process, testing and controls are the same.
1
Comparing to Humagen Blastomere Biopsy Micropipets, our Blastomere Biopsy Pipettes have a bigger variations in inner diameter (Sunlight 18-42 um vs Humagen 28-42 um). Other specifications, i.e., beveling and angulations, are the same.
Comparing to Humagen Polar Body Biopsy Micropipets, our Polar Body Biopsy Pipettes may have a spike draw on the tip. The inner diameter, beveling and angulations are the same.
Description of Device:
The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight.
The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences.
These devices are intended for one-time use and will be marked sterile.
These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.
Indications for Use:
Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
These devices are to be used by professionals trained in assisted reproduction technologies (ART). Federal law restricts these devices to sale by or on the order of a physician.
2
Substantial Equivalence:
These devices will be manufactured according to specified process controls and a Quality Assurance Program. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510K substantial equivalence.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR 3 0 2010
Dunsong Yang, M.D. President/CEO Sunlight Medical, Inc. 12443 San Jose Blvd. Suite 602 JACKSONVILLE FL 32223
Re: K092554
Trade/Device Name: Blastomere Biopsy Pipette and Polar Body Biopsy Pipette Regulation Number: 21 CFR §884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: MOH Dated: April 12, 2010 Received: April 13, 2010
Dear Dr. Yang:
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. 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 801); medical device reporting of medical device-related
4
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known): K092554
Device name: Blastomere Biopsy Pipettes
Indications for Use:
The Blastomere Biopsy Pipettes are tools used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of _2
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Premarket Notification - Sunlight Medical, Inc - Biopsy Pipettes
Indications For Use
510(k) Number (if known): K092554
Device name: Polar Body Biopsy Pipettes
Indications for Use:
The Polar Body Biopsy Pipettes are tools used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Theod L. Stole
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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