(89 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical, single-use glass pipette for manual biopsy procedures. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML.
No
The device is described as a tool for collecting cells for diagnostic purposes (preimplantation genetic diagnosis), not for treating or preventing a disease or condition.
No
Explanation: The device is a pipette intended for aspirating blastomeres for preimplantation genetic diagnosis (PGD), which is a diagnostic procedure. However, the device itself is a tool used in the collection of the sample for diagnosis, not the diagnostic device that performs the analysis or interpretation of the genetic material.
No
The device description clearly states the device is a physical pipette made of borosilicate glass with specific dimensions and packaging, indicating it is a hardware device.
Based on the provided information, the Swemed Blastomere Biopsy Pipette is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. The Swemed Blastomere Biopsy Pipette is a tool used to obtain the specimen (blastomeres) from the embryo. It is a surgical/procedural tool, not a diagnostic test itself.
- The intended use clearly states it's for conducting a blastomere biopsy in order to perform preimplantation genetic diagnosis (PGD). The PGD is the diagnostic test, which is performed on the genetic material obtained by the pipette.
- The description focuses on the physical characteristics of the pipette and its sterilization. This is typical for a surgical instrument.
- The text explicitly mentions that the tests for PGD are developed and their performance characteristics are determined by individual laboratories. This further reinforces that the pipette is a tool for obtaining the sample for these separate diagnostic tests.
In summary, the Swemed Blastomere Biopsy Pipette is a medical device used in a procedure (biopsy) that facilitates an IVD process (PGD), but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The Swemed Blastomere Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform pre-implantation genetic diagnosis on the genetic material in the biopsied cell(s).
The Swemed Blastomere Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of pre-implantation genetic diagnosis.
Product codes
85 MQH
Device Description
The Swemed Blastomere Pipette is manufactured by Swemed of borosilicate glass. The pipette has an inner diameter ranging from 0.030 mm to 0.049 mm and an outer diameter of either 0.053 mm or 0.060 mm. The pipette's length ranges from 55 to 65 mm. The Blastomere Pipette has a 20-35° beveled tip. The pipette is packaged in a silicone holder together with a glass tube. The tubes are then provided in seals made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
5 2002 NOV
Attachment 11
510(k) SUMMARY Swemed's Blastomere Biopsy Pipette
Submitter's Name, Address, Telephone Number, Contact Person
Carl C. Gage, Jr. Scan-Med, Inc. as U.S. distributor for Swemed Lab International AB Post Office Box 128 Middle Grove, New York 12850 or Telephone: (800) 722-6016 Facsimile: (888) 722-6633
Howard M. Holstein, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Telephone: (202) 637-5813 Facsimile: (202) 637-5910
Date Prepared: August 8, 2002
Name of Device and Name/Address of Sponsor
Swemed Blastomere Biopsy Pipette
Swemed Lab International AB by Scan-Med, Inc. as U.S. distributor for Swemed Lab International AB Post Office Box 128 Middle Grove, New York 12850 Telephone: (800) 722-6016 Facsimile: (888) 722-6633
Common or Usual Names
Blastomere Pipette
Classification Name
Assisted Reproduction Microtools Assisted Reproduction Accessory
Predicate Devices
Assisted Hatching/Zona Drilling Pipette component of Swemed's Follicle Aspiration Set Cook OB/GYN's Pre-Implantation Genetic Diagnosis Pipette
Humagen Fertility Diagnostics, Inc.'s Blastomere Biopsy Micropipette
1
Intended Use
The Swemed Blastomere Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform pre-implantation genetic diagnosis on the genetic material in the biopsied cell(s).
Indications for Use
The Swemed Blastomere Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of pre-implantation genetic diagnosis.
Technological Characteristics
The Swemed Blastomere Pipette is manufactured by Swemed of borosilicate glass. The pipette has an inner diameter ranging from 0.030 mm to 0.049 mm and an outer diameter of either 0.053 mm or 0.060 mm. The pipette's length ranges from 55 to 65 mm. The Blastomere Pipette has a 20-35° beveled tip. The pipette is packaged in a silicone holder together with a glass tube. The tubes are then provided in seals made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.
Basis for Substantial Equivalence
The Swemed Blastomere Pipette has the same intended use and indication for use as the predicate Cook and Humagen pipettes. The Swemed Blastomere Pipette is substantially equivalent in its technological characteristics to Swemed's Hatching/Zona Drilling Pipette. The only slight difference between the Swemed Blastomere Pipette and the Hatching/Zona Drilling Pipette is a minor variation in the ranges for the inside and outside diameters. This minor difference does not raise any new issues of safety or effectiveness, as the Blastomere Pipette's inner and outer diameter ranges are encompassed within the inner and outer diameter ranges of the Hatching/Zona Drilling Pipette.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Swemed Lab International AB % Mr. Howard M. Holstein, Esq. Hogan & Hartson L.L.P 555 13th Street, NW WASHINGTON DC 20004
Re: K022643 Trade/Device Name: Blastomere Biopsy
5 2002
NOV
Pipette H-55530 & H-55540 Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools
Regulatory Class: II Product Code: 85 MQH Dated: August 8, 2002 Received: August 8, 2002
Dear Mr. Holstein:
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
Page 2
This letter will allow you to begin marketing your device as described in your 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 this letter:
| (301) 594-4591 |
|---|
| (301) 594-4616 |
| (301) 594-4616 |
| (301) 594-4654 |
| (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" (21 CFR Part 807.97). 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
510(k) Number (if known): K022643
Swemed Blastomere Biopsy Pipette Device Name:
Indications for Use:
The Swemed Blastomere Biopsy Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
The Swemed Blastomere Biopsy Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of preimplantation genetic diagnosis.
This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the individual laboratories for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been cleared or approved by the Food and Drug Administration.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 C.F.R. 801.109) ✓