(62 days)
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No
The device description focuses on the physical characteristics and intended use of glass pipettes for manual manipulation in assisted reproduction, with no mention of software, algorithms, or data processing.
No
The device is used for micromanipulation and transfer of gametes or embryos in assisted reproduction methods, which are procedures rather than direct therapeutic treatments of a disease or condition in a living organism.
No
The device is described as pipettes used for physical manipulation (denuding, micromanipulating, holding, or transferring) of human gametes or embryos, not for diagnosing a condition or disease.
No
The device description clearly states the device is made of borosilicate glass and has specific physical dimensions, indicating it is a physical hardware device, not software.
Based on the provided information, the Swemed Pipettes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Swemed Pipettes' Intended Use: The Swemed Pipettes are used to physically manipulate human gametes and embryos outside the body for assisted reproduction procedures. They are tools for handling and processing these biological materials, not for analyzing them to diagnose or monitor a condition.
- Lack of Diagnostic Function: The description focuses on the physical manipulation of cells and embryos (denuding, holding, injecting, drilling). There is no mention of analyzing the composition, characteristics, or health of the gametes or embryos to provide diagnostic information.
Therefore, the Swemed Pipettes fall under the category of medical devices used in assisted reproductive technology procedures, but they do not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Swemed Pipettes are intended to be used to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ISCI, or other assisted reproduction methods.
The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Swemed Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Swemed Denuding Pipettes are used to remove the cumulus cell layers; and the Swemed Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.
Product codes (comma separated list FDA assigned to the subject device)
85 MQH
Device Description
The Swemed Pipettes are manufactured by Swemed of borosilicate glass. The pipettes have inner diameters ranging from .0048 - . 190 mm and outer diameters ranging from . 0068 - . 280 mm. The pipette length ranges from 50 to 90 mm. The Denuding Pipette does not have a beveled tip. The ICSI, the holding, and the Assisted Hatching/Zona Drilling Pipettes have a 30-35° beveled tip. The pipettes are packaged in a rubber holder together with a glass tube. The tube is then provided in a seal 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
JUL-08-99 17:50 From:HDGAN & HARTSON 7W 109 1111111111111111
T-048 P.05/08 -Job-947
JUL 19 1999
—
Attachment 11
510(k) SUMMARY Swemed's Follicle Aspiration Set
Submitter's Name, Address, Telephone Number, Contact Person
Carl Gage Scan-Med, Inc. as U.S. distributor ------------------------------------------------------------------------------------------------------------------------------------------for Swemed Lab International AB Post Office Box 128 Middle Grove, New York 12850 OL Telephone: (800) 722-6016 Facsimile: (888) 722-6633
Edward C. Wilson, Jr., Esq. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Telephone: (202) 637-5839 Facsimile: (202) 637-5910
July 8, 1999 Date Prepared:
Name of Device and Name/Address of Sponsor
Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes
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
Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes
Classification Name
Assisted Reproduction Microtools
Predicate Devices
Cook OB/GYN Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes
Intended Use
The Swemed Pipettes are intended to be used to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ISCI, or other assisted reproduction methods.
1
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Indications for Use
The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Swemed Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Swemed Denuding Pipettes are used to remove the cumulus cell layers; and the Swemed Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.
Technological Characteristics
The Swemed Pipettes are manufactured by Swemed of borosilicate glass. The pipettes have inner diameters ranging from .0048 - . 190 mm and outer diameters ranging from . 0068 - . 280 mm. The pipette length ranges from 50 to 90 mm. The Denuding Pipette does not have a beveled tip. The ICSI, the holding, and the Assisted Hatching/Zona Drilling Pipettes have a 30-35° beveled tip. The pipettes are packaged in a rubber holder together with a glass tube. The tube is then provided in a seal 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 Pipettes have the same intended use as the predicate devices, the Cook Pipettes: to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods. The Swemed Pipettes also have the same indications for use as the predicate devices, the Cook Pipettes: the Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Denuding Pipettes are used to remove the cumulus cell layers; and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching. Except for two minor features, the Swemed Pipettes and the Cook Pipettes are very similar devices. The primary differences between the Swemed Pipettes and the Cook Pipettes are that: (1) the inside and outside diameters, pipette lengths, and bevel angles are slightly different; and (2) the Cook Denuding Pipettes can be ordered with a mouth aspiration tubing line, whereas the Swemed Denuding Pipettes are intended for use with a vacuum device. These minor differences do not affect the safety or effectiveness of the device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 19 1999
Swemed Lab International AB c/o Mr. Edward C. Wilson, Jr. Hogan & Hartson, L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 Re: K991700 Swemed Micropipettes Dated: May 18, 1999 Received: May 18, 1999 Requlatory Class: II 21 CFR §884.6130/Procode: 85 MQH
Dear Mr. Wilson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 13
510(k) Number (if known): 991700
Device Name:
Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes; Swemed Holding Pipettes; Swemed Denuding Pipettes; and Swemed Assisted Hatching/Zona Drilling Pipettes
Indications for Use:
The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the oocyte in position with the application of vacuum during single sperm injection with the microinjection pipette, the Denuding Pipettes are used to remove the cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.
(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)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K991700