(225 days)
Not Found
No
The device description and performance studies focus on physical properties, sterilization, and basic functionality of a manual pipette, with no mention of AI or ML.
No
The device is described as a tool for handling and transferring liquids, media, and gametes, which are laboratory procedures, not direct treatment or diagnosis. It also explicitly states that the "pipettes will not come in contact with the human body during use."
No
The device is described as a tool for handling and transferring liquids, media, and gametes, which are laboratory and procedural tasks, not diagnostic ones. It does not analyze any physiological parameters or provide information for disease identification or prognosis.
No
The device description clearly states it is a physical pipette made of low-density polyethylene, intended for handling liquids and gametes. It is a hardware device.
Based on the provided information, the Pasteur Pipettes are likely considered an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states "handling and transferring of liquids, media and gametes during assisted reproductive technology procedures." ART procedures involve manipulating biological materials (gametes) in vitro (outside the body) for diagnostic or therapeutic purposes related to fertility.
- Device Description: The device is used to handle and transfer "liquids, media and gametes." Gametes are biological specimens.
- Performance Studies: The performance studies include tests like "Mouse Embryo Assay (MEA)" and "Endotoxin testing per USP." These are tests commonly performed on materials and devices used in procedures involving the manipulation of biological samples and cell cultures, which are characteristic of IVD activities.
- Predicate Device: The predicate device is also described as "Pasteur Pipet - Sterile," and the context of its use in fertility diagnostics (Humagen Fertility Diagnostics, Inc.) further supports the classification of such pipettes as being used in an IVD context.
While the device itself doesn't perform a diagnostic test on a sample, it is an essential tool used in the process of an in vitro diagnostic or therapeutic procedure (ART). The handling and transfer of gametes and media are critical steps in these procedures, and the quality and sterility of the pipette directly impact the outcome of the in vitro process.
Therefore, the device fits the definition of an IVD device as it is an accessory or component used in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.
Product codes (comma separated list FDA assigned to the subject device)
MQK
Device Description
The Pasteur Pipettes are radiation-sterilized, single use, transparent low-density polyethylene pipettes intended for handling and transferring of liquids, media and gametes during assisted reproductive technology (ART) procedures. The pipettes are provided in two sizes, 1 mL (Model 16201) and 3 mL (Model 16202). Each pipette includes an integrated bulb end that is used to aspirate and expel liquid, media and gamete to and from the device. The pipettes also include a molded volume scale along the body of the pipette. The volume scale only provides an estimate of the aspirated volume. The pipettes will not come in contact with the human body during use.
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)
4.1 Sterile validation
The subject devices are gamma irradiation sterilized. The sterilization process and validation methods were done in accordance with ISO 11137-1:2006 and ISO 11137-2:2013. The sterilization assurance level of the subject devices is 10-6.
4.2 Package Validation
Verification of the ability of device packaging to maintain a sterile barrier over the two-year shelf-life of the device was assessed using the following methods:
- Seal strength testing according to ASTM F88/F88M-15 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
- Dye penetration test according to ASTM F3039-15 "Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration"
- Visual inspection according to ASTM F1886/F1886M-16 "Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection"
Testing demonstrated that the sterile barrier was maintained over the two-year shelf-life.
4.3 Transport Testing
Simulated transport testing was conducted to demonstrate the ability of device packaging to withstand the rigors of shipping. Testing was performed in accordance with ASTM D4169-16.
4.4 Stability and Shelf life
The proposed shelf-life of the subject device is two years. The following tests were conducted on newly manufactured devices and devices after accelerated aging in accordance with ASTM F1980-16:
- Mouse Embryo Assay (MEA (1-cell, expanded blastocyst within 96 hours) ≤80%)
- Endotoxin testing per USP (
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2020
HertART ApS Ann-Catherine Ericson RA Manager Gustaf Werners gata 2 Västra Frölunda, SE-421 32 Sweden
K201213 Re:
Trade/Device Name: Pasteur Pipette 3mL, Pasteur Pipette 1mL Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted Reproduction Labware Regulatory Class: II Product Code: MQK Dated: November 2, 2020 Received: November 18, 2020
Dear Ann-Catherine Ericson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201213
Device Name Pasteur Pipette 3mL, Pasteur Pipette 1 mL
Indications for Use (Describe)
The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "HertART" in blue and red font. The word "Hert" is in blue, and the word "ART" is in red. To the right of the word "HertART" is the phrase "at the beginning of life" in blue font. The text is on a white background.
510(k) Summary - K201213
Date prepared: December 7, 2020
| Applicant: | HertART ApS
Gustaf Werners gata 2
SE-421 32 Västra Frölunda
Sweden
Phone: +46 (0) 708 22 80 28
Email: psvensson@vitrolife.com
Fax: +46 (0) 31 721 80 90 |
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person: Ann-Catherine Ericson RA Manager Phone: +46 (0) 701 64 88 36 Email: aericson@vitrolife.com
Device Information 1
Trade Name: Pasteur Pipette 3mL, Pasteur Pipette 1mL Common name: Pasteur Pipettes Regulation number: 21 CFR 884.6160 Regulation name: Assisted Reproduction Labware Product code: MQK (Labware, Assisted Reproduction) Class: II
1.1 Predicate Device:
K000915 - Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75, Humagen Fertility Diagnostics, Inc.
The predicate has not been subject to a pipette design-related recall.
2 Device description
The Pasteur Pipettes are radiation-sterilized, single use, transparent low-density polyethylene pipettes intended for handling and transferring of liquids, media and gametes during assisted reproductive technology (ART) procedures. The pipettes are provided in two sizes, 1 mL (Model 16201) and 3 mL (Model 16202). Each pipette includes an integrated bulb end that is used to aspirate and expel liquid, media and gamete to and from the device. The pipettes also include a molded volume scale along the body of the pipette. The volume scale only provides an estimate of the aspirated volume. The pipettes will not come in contact with the human body during use.
4
Image /page/4/Picture/1 description: The image shows the logo for HertART. The word "Hert" is in blue, and the word "ART" is in red. The words "at the beginning of life" are in blue and are located to the right of the word "ART". The logo has a reflection underneath it.
2.1 Indications for Use
The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.
Comparison of Subject and Predicate Device Intended Use and 3 Technological Characteristics
| Attribute | Subject Device
Pasteur Pipette
K201213 | Predicate Device
Pasteur Pipet
K000915 | Differences |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Pasteur Pipettes
are intended for
handling and
transferring of liquids,
media and gametes
during assisted
reproductive
technology procedures. | Pasteur pipets are a
general laboratory
pipette to be used
anytime there is a need
to move fluid or cells.
They may also be used
to "denuda" ova prior to
an ivf procedure. | The indications for the subject and
predicate devices are not identical. Both
the predicate and subject devices are
indicated for handling of gametes, media,
and other fluids; however, the predicate is
also indicated for use in denuding oocytes.
This difference only represents a more
limited use of the subject devices as
compared to the predicate and does not
impact the overall intended use of the
devices (handling and transferring fluids,
media, and gametes used in assisted
reproduction procedures), which are the
same. |
| Design | Single piece molded
Pasteur pipette | Glass Pasteur pipette to
be used with separate
bulb | Different: There are differences in the
designs of the subject and predicate
devices; however, they do not raise
different questions of safety and
effectiveness (S&E). |
| Material | Low density
polyethylene | Borosilicate glass | Different: The subject and predicate device
materials are not the same. Differences in
materials do not raise different questions of
S&E. |
| Size | 15.2 cm | 5.75" (14.6cm) and 9"
(22.9cm) | Different: Both the 1 mL and 3 mL subject
devices have the same length, which is
different than the predicate that is provided
in two lengths. Differences in length do not
raise different questions of S&E. |
| Volume
capacity | 1 mL and 3 mL | Unknown | Different: The volume capacity of the
predicate is not known; however,
differences in volume capacity do not raise
different questions of S&E. |
| Packaging | Peel open pouch
consisting of PE/PA-
film and a BOPET /
Adhesive / EZ Peel®
Sealant
500 pouches of one
pipette each packed in
a cardboard box | Material of pouches not
known.
30 pouches of three
pipettes each packed in
boxes of 90 (30
pouches) | Different: Packaging is different for the
subject device as compared to the predicate
device. Differences in packaging do not
raise different questions of S&E. |
| Sterile | Yes - Gamma
irradiation | Yes -Dry heat | Different: Different sterilization methods
are used for the subject and predicate
devices. Differences in sterilization
methods do not raise different questions of
S&E. |
| Shelf-life | 2 years | Unknown | Different: The shelf-life of the predicate is
not known; however, differences in shelf-
life do not raise different questions of S&E. |
| Endotoxin
testing
(LAL) | ≤ 0.25 EU/device | LAL tested, limits not
specified | Different: Endotoxin testing was
conducted on the predicate device;
however, the acceptance specification is not
known. Differences in endotoxin testing do
not raise different questions of S&E. |
| Mouse
Embryo
Assay
(MEA) | ≥ 80% 1-cell expanded
blastocyst within 96
hours | MEA tested, limits not
specified | Different: MEA testing was conducted on
the predicate device; however, the
acceptance specification is not known.
Differences in MEA testing do not raise
different questions of S&E. |
5
Image /page/5/Picture/1 description: The image shows the word "HertART" in blue and red font, followed by the phrase "at the beginning of life" in blue font. The word "Hert" is in blue, while "ART" is in red. The phrase "at the beginning of life" is smaller in size compared to the word "HertART". The text is horizontally aligned and appears to be a logo or title.
As stated in the table, the subject and predicate devices have similar indications for use statements and have the same intended use (i.e., handling and transferring fluids, media, and gametes used in assisted reproduction procedures).
The subject and predicate devices have differences in technological characteristics, including their design, materials, packaging, etc. As stated in the table, the differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
Non-clinical Performance Data 4
4.1 Sterile validation
The subject devices are gamma irradiation sterilized. The sterilization process and validation methods were done in accordance with ISO 11137-1:2006 and ISO 11137-2:2013. The sterilization assurance level of the subject devices is 10-6.
6
Image /page/6/Picture/1 description: The image shows the logo for HertART. The word "Hert" is in blue, and the letters "ART" are in red. The tagline "at the beginning of life" is in blue and is located to the right of the red "ART".
4.2 Package Validation
Verification of the ability of device packaging to maintain a sterile barrier over the two-year shelf-life of the device was assessed using the following methods:
- Seal strength testing according to ASTM F88/F88M-15 "Standard Test Method for Seal ● Strength of Flexible Barrier Materials"
- . Dye penetration test according to ASTM F3039-15 "Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration"
- . Visual inspection according to ASTM F1886/F1886M-16 "Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection"
Testing demonstrated that the sterile barrier was maintained over the two-year shelf-life.
4.3 Transport Testing
Simulated transport testing was conducted to demonstrate the ability of device packaging to withstand the rigors of shipping. Testing was performed in accordance with ASTM D4169-16.
4.4 Stability and Shelf life
The proposed shelf-life of the subject device is two years. The following tests were conducted on newly manufactured devices and devices after accelerated aging in accordance with ASTM F1980-16:
- Mouse Embryo Assay (MEA (1-cell, expanded blastocyst within 96 hours) ≤80%)
- Endotoxin testing per USP (