(272 days)
Rapid-i™ is a cryopreservation device indicated to be used to contain, vitrify and maintain 4-8 cell stage embryos
Rapid-i™ is a device intended for the vitrification of 4-8 cell stage embryos through vitrification. Rapid-iTM consists of the following two items:
- . A Polymethyl Methacrylate (PMMA) stick, 80 mm long and 2 mm in diameter
- A Polyvinyl Chloride (PVC) straw, 165 mm long and 3 mm in . diameter, equipped with a stainless steel weight
- The two parts are packed in a TYVEK® bag and sterilised by ionizing radiation
I cannot provide acceptance criteria and study details as the input document is a 510(k) premarket notification summary for a medical device (Rapid-i™ cryopreservation container and microtool). This type of document declares substantial equivalence to a predicate device and does not typically include detailed performance studies with acceptance criteria in the manner you've requested for typical AI/ML-based device evaluations. The document focuses on demonstrating that the new device has similar intended use and technological characteristics to an already approved device.
Here's why the information you're asking for is not present or applicable in this context:
- Acceptance Criteria & Reported Device Performance (Table 1): The document affirms that the Rapid-i™ has "similar intended use as the predicate device... and similar technological characteristics related to safety and effectiveness." It doesn't present specific performance metrics (e.g., sensitivity, specificity, accuracy, or a quantitative measure of embryo viability/survival rate) with predefined acceptance criteria. Instead, it relies on the established safety and effectiveness of the predicate device.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set Details (Points 2-9): These points are highly relevant for modern AI/ML-based medical devices or devices undergoing rigorous clinical performance trials. This 510(k) pertains to a physical microtool used in assisted reproduction. The "study" here is primarily a comparison of material properties, design, and intended use against a legally marketed predicate, rather than a clinical trial generating novel performance data against a ground truth.
What the document does convey regarding "performance" is:
- Substantial Equivalence: The core "finding" or "proof" is the FDA's determination that the Rapid-i™ is substantially equivalent to the predicate device (CryoTip™ K041562). This implies that its performance, as it relates to safety and effectiveness for its intended use, is considered equivalent to a device already on the market.
- Safety Considerations: The document discusses the likelihood of contamination from liquid nitrogen being "very small" due to the device's design (distance from liquid nitrogen surface, air pocket, liquid nitrogen transition to gas). It also states that "samples can not thaw when the straw is sealed after placement in liquid nitrogen if the instructions in the Package Insert are followed." These are statements related to the design features meant to ensure safety and maintain expected performance rather than measured performance results from a study.
- Maintenance of Embryos: The intended use states the device is "intended to be used to contain, vitrify and maintain 4-8 cell stage embryos." The "performance" in this context is the successful vitrification and maintenance of embryos, which is assumed to be equivalent to the predicate device.
In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not a performance study for an AI/ML algorithm or a device requiring detailed clinical efficacy data against a ground truth.
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DEC 2 3 2009
X. PREMARKET NOTIFICATION SUMMARY
Submitted by:
Vitrolife Sweden AB Box 9080 SE-400 92 Göteborg SWEDEN
Contact Person:
Mr Kjell Kjörk Vitrolife Sweden AB Box 9080 SE-400 92 Göteborg SWEDEN Phone +46 31 721 80 77 +46 31 721 80 90 Fax Mail kkjork@vitrolife.com
Date Prepared:
Trade Name:
Rapid-i™
MQK
8 December 2009
Common Name:
Cryopreservation container and microtool
Classification Name:
Assisted Reproduction Labware (21 C.F.R. § 884.6160)
Product Code:
Predicate Device:
CryoTip™ (K041562)
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Description of the Device:
Rapid-i™ is a modification of the CryoTip™ microtool from Irvine Scientific Sales Co., Inc. (K041562), has similar intended use as the predicate device, and similar technological characteristics related to safety and effectiveness. This submission contains information demonstrating substantial equivalence between these two devices.
Rapid-i™ is a device intended for the vitrification of 4-8 cell stage embryos through vitrification. Rapid-iTM consists of the following two items:
- . A Polymethyl Methacrylate (PMMA) stick, 80 mm long and 2 mm in diameter
- A Polyvinyl Chloride (PVC) straw, 165 mm long and 3 mm in . diameter, equipped with a stainless steel weight
- � The two parts are packed in a TYVEK® bag and sterilised by ionizing radiation
The likelihood of contamination from the liquid nitrogen is very small since the distance is from the surface of the liquid nitrogen to the opening of the straw is at least 50 mm and most of that distance is occupied by air at 20℃. Liquid nitrogen will make the transition to gas at -196°C. It is even more unlikely that any viral contaminants which could be present in the liquid nitrogen would contaminate the embryo of the same reason.
The samples can not thaw when the straw is sealed after placement in liquid nitrogen if the instructions in the Package Insert are followed.
The minimum distance from the surface of the liquid nitrogen and the top of the straw is 45 mm. It is evident from the geometry that the embryo can not come in contact with the straw during insertion or removal. The surface tension keeps the embryo safely in place.
Intended Use
Rapid-i™ is a cryopreservation device that is intended to be used to contain, vitrify and maintain 4-8 cell stage embryos.
Technological Characteristics:
The device Rapid-i™ is a modification of CryoTip™ (K041562). Rapid-i™ has similar intended use as the predicate device (K041562), and similar technological characteristics related to safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows a partial view of a logo or emblem. The left side features the words "DEPARTMENT OF HEALTH &" arranged vertically along a curved path. To the right of the text is a stylized graphic consisting of three curved, parallel lines that resemble a bird in flight or a flowing ribbon. The overall impression is that of a government health organization.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC 2 3 2009
Food and Drug Administration 10903 New Hampshire Avenue. Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Kjell Kjörk Pharmacist, Senior Regulatory Affairs Manager Vitrolife Sweden AB Box 9080, SE-400 92, Göteborg SWEDEN
Re: K090832 Trade/Device Name: Rapid-i™ Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MQK Dated: December 9, 2009 Received: December 11, 2009
Dear Mr. Kjörk:
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 indicons 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, intring 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. Your wort 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
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Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); 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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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XI. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K090832
Device Name:
Rapid-i™
Indications for Use:
Rapid-i™ is a cryopreservation device indicated to be used to contain, vitrify and maintain 4-8 cell stage embryos
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 C.F.R. § 801.109)
Over-the Counter Use_
Aozin Whing
OR
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
§ 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.