Pasteur Pipette 3mL, Pasteur Pipette 1mL

K201213 · Hertart Aps · MQK · Dec 16, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K201213
• Device Name: Pasteur Pipette 3mL, Pasteur Pipette 1mL
• Applicant: Hertart Aps
• Product Code: MQK · Obstetrics/Gynecology
• Decision Date: Dec 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6160
• Device Class: Class 2

Indications for Use

The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.

Device Story

Pasteur Pipettes are single-use, radiation-sterilized, low-density polyethylene pipettes used in assisted reproductive technology (ART) labs. Available in 1 mL and 3 mL sizes, each device features an integrated bulb for manual aspiration and expulsion of liquids, media, and gametes. The device body includes a molded volume scale for estimation. Operated by laboratory personnel, the pipettes facilitate fluid transfer during ART procedures. The device does not contact the human body. Benefits include sterile, single-use handling of sensitive reproductive materials.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via Mouse Embryo Assay (MEA) (≥80% 1-cell expanded blastocyst within 96 hours), endotoxin testing (USP <85>, ≤0.25 EU/device), and packaging integrity (ASTM F88, F3039, F1886). Shelf-life and stability confirmed via accelerated aging (ASTM F1980) and simulated transport testing (ASTM D4169).

Technological Characteristics

Materials: Low-density polyethylene. Design: Single-piece molded pipette with integrated bulb and volume scale. Sterilization: Gamma irradiation (ISO 11137-1, ISO 11137-2) to SAL 10^-6. Packaging: Peel-open pouch (PE/PA-film and BOPET). Shelf-life: 2 years. No electronic or software components.

Indications for Use

Indicated for handling and transferring liquids, media, and gametes during assisted reproductive technology (ART) procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75 (K000915)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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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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<br>Gustaf Werners gata 2<br>SE-421 32 Västra Frölunda<br>Sweden<br>Phone: [phone]<br>Email: [e-mail]<br>Fax: [phone] |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Contact Person: Ann-Catherine Ericson RA Manager Phone: [phone] Email: [e-mail]

### 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.

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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<br>Pasteur Pipette<br>K201213 | Predicate Device<br>Pasteur Pipet<br>K000915 | Differences |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Pasteur Pipettes<br>are intended for<br>handling and<br>transferring of liquids,<br>media and gametes<br>during assisted<br>reproductive<br>technology procedures. | Pasteur pipets are a<br>general laboratory<br>pipette to be used<br>anytime there is a need<br>to move fluid or cells.<br>They may also be used<br>to "denuda" ova prior to<br>an ivf procedure. | The indications for the subject and<br>predicate devices are not identical. Both<br>the predicate and subject devices are<br>indicated for handling of gametes, media,<br>and other fluids; however, the predicate is<br>also indicated for use in denuding oocytes.<br>This difference only represents a more<br>limited use of the subject devices as<br>compared to the predicate and does not<br>impact the overall intended use of the<br>devices (handling and transferring fluids,<br>media, and gametes used in assisted<br>reproduction procedures), which are the<br>same. |
| Design | Single piece molded<br>Pasteur pipette | Glass Pasteur pipette to<br>be used with separate<br>bulb | Different: There are differences in the<br>designs of the subject and predicate<br>devices; however, they do not raise<br>different questions of safety and<br>effectiveness (S&E). |
| Material | Low density<br>polyethylene | Borosilicate glass | Different: The subject and predicate device<br>materials are not the same. Differences in<br>materials do not raise different questions of<br>S&E. |
| Size | 15.2 cm | 5.75" (14.6cm) and 9"<br>(22.9cm) | Different: Both the 1 mL and 3 mL subject<br>devices have the same length, which is<br>different than the predicate that is provided<br>in two lengths. Differences in length do not<br>raise different questions of S&E. |
| Volume<br>capacity | 1 mL and 3 mL | Unknown | Different: The volume capacity of the<br>predicate is not known; however,<br>differences in volume capacity do not raise<br>different questions of S&E. |
| Packaging | Peel open pouch<br>consisting of PE/PA-<br>film and a BOPET /<br>Adhesive / EZ Peel®<br>Sealant<br>500 pouches of one<br>pipette each packed in<br>a cardboard box | Material of pouches not<br>known.<br>30 pouches of three<br>pipettes each packed in<br>boxes of 90 (30<br>pouches) | Different: Packaging is different for the<br>subject device as compared to the predicate<br>device. Differences in packaging do not<br>raise different questions of S&E. |
| Sterile | Yes - Gamma<br>irradiation | Yes -Dry heat | Different: Different sterilization methods<br>are used for the subject and predicate<br>devices. Differences in sterilization<br>methods do not raise different questions of<br>S&E. |
| Shelf-life | 2 years | Unknown | Different: The shelf-life of the predicate is<br>not known; however, differences in shelf-<br>life do not raise different questions of S&E. |
| Endotoxin<br>testing<br>(LAL) | ≤ 0.25 EU/device | LAL tested, limits not<br>specified | Different: Endotoxin testing was<br>conducted on the predicate device;<br>however, the acceptance specification is not<br>known. Differences in endotoxin testing do<br>not raise different questions of S&E. |
| Mouse<br>Embryo<br>Assay<br>(MEA) | ≥ 80% 1-cell expanded<br>blastocyst within 96<br>hours | MEA tested, limits not<br>specified | Different: MEA testing was conducted on<br>the predicate device; however, the<br>acceptance specification is not known.<br>Differences in MEA testing do not raise<br>different questions of S&E. |

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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.

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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<85> (<0.25 EU/device) ●
- Visual inspection (no scratches or discolorization)
- Testing to ensure liquid can be aspirated and maintained within the device ●
- . Volume marker validation testing

### 5 Conclusions

The results of the testing described above demonstrate that the Pasteur Pipette 1mL and Pasteur Pipette 3mL are as safe and effective as the predicate and supports a determination of substantial equivalence.