(303 days)
ProInsert™ is used during preparation of human sperm from a semen sample using density gradient separation during assisted reproductive procedures. ProInsert™ facilitates density gradient preparation and pellet retrieval following density gradient separation.
ProInsert™ is packaged in a sterile pouch, is single-use only, and includes the following components: Two 15 mL Conical Centrifuge tubes (one for the density gradient preparation and one for washing) 2 Pellet Retrieval Pipettes 1 ProInsert™
Here's a breakdown of the acceptance criteria and the study information for the ProInsert™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Specifications: | |
| Shelf life | 1 year |
| Endotoxin level | Less than 1.0 EU/device |
| Sterility | Gamma irradiated - SAL 10⁻⁶ |
| Human Sperm Survival Assay (HSSA) | Greater than 80% motility following 24h exposure to device materials |
| Functionality Testing: | |
| Gradient separation effectiveness | Tested using the ProInsert as compared to conventional separation procedures. (Implication: met standards for effectiveness, though specific numerical results are not provided in this summary.) |
| Endotoxin testing | Performed (Implied compliance with the < 1.0 EU/device limit) |
| Sterility Validation | Performed (Implied compliance with SAL 10⁻⁶) |
| Shelf Life Testing | Performed (Implied compliance with 1 year shelf life) |
| Package Integrity Testing | Performed (Implied that package integrity is maintained) |
| Material Safety Testing - HSSA | Performed (Implied compliance with > 80% motility, matching the device specification) |
Study Proving Device Meets Acceptance Criteria:
The document describes "Performance testing: functionality testing" and "Lot Release Tests" as the studies conducted.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a separate sample size for a "test set" in the context of clinical or comparative studies. The testing described appears to be a series of laboratory-based performance and safety evaluations.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of the tests (e.g., endotoxin, sterility, HSSA), they are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of testing described for the ProInsert™. The "ground truth" for the performance criteria (e.g., endotoxin levels, sterility, sperm motility percentage) would be established by validated laboratory assays and measurement standards, not by expert consensus in this context.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in clinical studies where individual assessments or interpretations are involved (e.g., image reading). The tests described are objective laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI Assistance:
No, an MRMC comparative effectiveness study was not done. The ProInsert™ is a physical labware device, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
No, a standalone study (in the context of an algorithm) was not done. The ProInsert™ is a physical medical device; there is no AI algorithm involved in its primary function.
7. The Type of Ground Truth Used:
The ground truth for the device's performance relies on objective laboratory measurements and validated assay results.
- Endotoxin: Measured against a quantitative limit (less than 1.0 EU/device).
- Sterility: Measured against a quantifiable sterility assurance level (SAL 10⁻⁶).
- Human Sperm Survival Assay (HSSA): Measured as a percentage of sperm motility.
- Functionality (gradient separation effectiveness): Compared to conventional separation procedures, implying successful implementation of the intended function.
8. The Sample Size for the Training Set:
This information is not applicable. There is no AI algorithm being trained for this device. The "training set" concept is typically used in machine learning or AI development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for an AI algorithm.
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FEB 2 0 2014
510(k) Summary K131145 Nidacon International AB Flöjelbergsgatan 16 B SE-431 37 Mölndal Sweden Tel: +46-31-703 06 30 Fax: +46-31-40 54 15 E-mail: contact@nidacon.se
Image /page/0/Picture/3 description: The image shows a symbol that looks like a combination of a teardrop shape and a crescent. The teardrop shape is positioned above the crescent, with the pointed end of the teardrop facing downwards. The crescent is open at the top, creating a gap between its ends and the teardrop shape. The symbol is drawn in black and white, with a slightly rough or textured appearance.
Date Prepared: February 13, 2014 Contact: Magda Alic Holmes, Vice President Tradename: ProInsert™ Common Name: Plastic insert for centrifuge tube Classification name: Assisted reproduction labware (21 CFR, 884.6160, Product code: MQK)
Indications for use:
ProInsert™ is used during preparation of human sperm from a semen sample using density gradient separation during assisted reproductive procedures. ProInsert™ facilitates density gradient preparation and pellet retrieval following density gradient separation.
Description:
ProInsert™ is packaged in a sterile pouch, is single-use only, and includes the following components: Two 15 mL Conical Centrifuge tubes (one for the density gradient preparation and one for washing) 2 Pellet Retrieval Pipettes
1 ProInsert™
Image /page/0/Figure/10 description: The image shows a diagram of a ProInsert device, a pellet retrieval pipette, and a screw cap. The ProInsert has markings from 9 to 14. The pellet retrieval pipette is connected to the ProInsert. The screw cap is separate from the other two items.
Device function/Scientific Concept
Density gradient separation of sperm is performed to separate sperm from unwanted contaminants (e.g., abnormal or immature sperm. Ivmphocytes, cell debris, etc.). Generally, this involves layering semen over two layers of separation media of different density, followed by centrifugation to obtain a sperm pellet that leaves unwanted contaminants in the separation media above. Currently, to retrieve the pellet. a user must pass a retrieval pipette through the upper layers of the gradient above the pellet. The ProInset™ aids in recovery of the sperm pellet as it resides within the separation tube throughout the separation procedure. Following sperm pellet can be retrieved by passing the Pellet Retrieval Pipette through the insert channel that avoids contact with gradient separation media above the pellet.
Device specifications:
Shelf life: 1 year Endotoxin level: less than 1.0 EU/device. Sterility: Gamma irradiated - SAL 10°0 Human Sperm Survival Assay (HSSA): Greater than 80% motility following 24h exposure to device materials
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Products claimed for substantial equivalence:
Substantial equivalence is being supported by the Federal Register Notice Final Rule entitled "Obsteric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures" (FR 63(175):48428-37). This equivalence is supported by the summary statement:
Upon the effective date, the Federal Register document may be cited in the absence of an existing predicate device which would be used to support substantial equivalence.
Fifteen milliliter centrifuge tubes historically have been a common piece of labware used in sperm gradient separation procedures. The proposed device differs from currently available 15 ml centrifuge tubes in that it includes an insert that facilitates gradient loading and recovery of the sperm pellet after completion of the procedure.
Performance testing: functionality testing
The ProInsert™ was tested with the following tests:
- Functionality testing gradient separation effectiveness using the ProInsert as compared to conventional separation procedures
- ۔ Endotox in testing
- -Sterility Validation.
- Shelf Life Testing -
- Package Integrity Testing -
- -Material Safety Testing - HSSA
Lot Release Tests:
For the release of each production batch of this product, visual, performance, sterility, endotoxin analysis, and HSSA (human sperm survival) testing is done.
Conclusion
The testing performed demonstrates that this product meets design and testing requirements for assisted reproductive labware provided in 21 CFR 884.6160.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administrution 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20. 2014
NidaCon International AB % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, FL 34114
Re: K131145
Trade/Device Name: ProInsert™M Regulation Number: 21 CFR$ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: January 16, 2014 Received: January 22, 2014
Dear Daniel Kamm.
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 cnclosure) 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.
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Page 2 - Daniel Kamm, P.E.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K131145
Device Name ProInsert™
Indications for Use (Describe)
ProInsen™ is used during preparation of human semen sample using density gradient separation during assisted reproductive procedures. ProInser1™ facilitates density gradient preparation and pellet retrieval following density gradient separation.
Type of Use (Select one or both, as applicable) [x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . . ・・・ : : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Herbert P. Lerner 2014.02.20 14:33:43
FORM FDA 3881 (1/14)
. . . . . .
§ 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.