(75 days)
The embryo transfer catheter set is a sterile, single use device designed for in vitro fertilized (IVF) embryo transfer into the uterine cavity.
The trial transfer catheter is a sterile, single use device which is designed for ensuring a free passage through the cervix prior to the embryo transfer.
The stylet is a sterile, single-use device designed to support in initial placement of the guide catheter prior to the embryo transfer.
Embryo Transfer Catheter Set: The Swemed Embryo Transfer Catheter Set is manufactured by Swemed of medical grade polymers. The device consists of a two piece assembly comprised of an embryo transfer catheter and a detachable guide catheter (outer sheath). The overall length of the assembly ranges from 190 mm to 250 mm. The outer diameter of the transfer catheter is approximately 1.4 mm and the outer diameter of the guide catheter is approximately 2.3 mm. The catheter sets are packaged separately or assembled in an double barrier sterilisation pouch/wrapping. All devices are sterilized using e-beam irradiation.
Trial Transfer Catheter Set: The Swemed Trial Transfer Catheter Set is manufactured by Swemed and is identical to the Swemed Transfer Catheter Set except for tip design and packaging configuration. The differences are that the tip is closed, i.e. no hole, and that it is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation.
Stylet: The Swemed stylet is manufactured by Swemed of medical grade polymers and stainless steel. The stylet consists of a handle (polyurethane) and polymer (polytetraflourethene) covered stainless steel wire. The Swemed stylet is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation.
The provided document is a 510(k) summary for the Swemed ClearVision™ Embryo Transfer Catheter Set and accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria in terms of performance metrics.
Therefore, the document does not contain the requested information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth details for testing or training sets.
The summary of the document states:
"Swemed Lab International AB, believes that the subject devices are substantially equivalent to the predicate devices. The subject devices has the same intended use/indications for use, in principle the same dimensions, complies with the same standards/special controls. The differences are the sterilization method used and a minor difference in material composition. Based on the comparison of the Swemed Clearvision™ Embryo Transfer Catheter Set and accessories to the predicate devices the conclusion is made that no new questions of safety and effectiveness are raised. Therefore, it is concluded that the requirements for substantial equivalence for the proposed devices are met."
This indicates that the "study" proving the device meets its "acceptance criteria" (in the context of a 510(k)) is a comparative analysis of the device's technical characteristics, intended use, and indications for use against existing predicate devices. The acceptance criteria, in this case, are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, despite minor differences in sterilization method and material composition.
Without specific performance metrics being the basis for the 510(k) submission, the requested table and detailed study parameters are not applicable or extractable from this document.
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K053208
page 1 of 3
JAN 3 0 2006
8. 510 (k) SUMMARY
Swemed Clearvision™ Embryo Transfer Catheter Set and accessories
November 7th 2005 DATE SUBMITTED:
SUBMITTER: Swemed Lab International AB Billdalsvägen 2 SE-427 36 Billdal Sweden
CONTACT PERSON: Mr. Anders Johansson Quality Assurance / Regulatory Affairs Manager
Swemed Lab International AB Billdalsvägen 2 SE-427 36 Billdal Sweden
Phone: +46 31 687777 +46 31 680011 Hax: Mail: anders@swemed.com
DEVICE NAME:
Trade Name
ClearVision™ Embryo Transfer Catheter Set ClearVision™ Trial Transfer Catheter Sct ClearVision™ Stylet
Common Name
Embryo Transfer Catheter (ETC) Trial Transfer Catheter Stylet/Obturator
Classification Name
Assisted Reproduction Catheters
PREDICATE DEVICES:
a) Wallace Catheters already marketed in the USA under Premarket Notification K990350
b) CooperSurgical Embryo Transfer Catheter already marketed in the USA under Premarket Notification K023379
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K053208
розегов
c) Wallace Trial Transfer Catheters already marketed in the USA under Premarket Notification K990348
d) CooperSurgical Trial Transfer Catheter already marketed in the USA under Premarket Notification K023384
e) Wallace Malleable Stylet already marketed in the USA under Premarket Notification K990349
f) CooperSurgical Malleable Stylet already marketed in the USA under Premarket Notification K023382.
DEVICE DESCRIPTION:
Embryo Transfer Cathteter Set
The Swemed Embryo Transfer Catheter Set is manufactured by Swemed of medical grade polymers. The device consists of a two picce assembly comprised of an embryo transfer catheter and a detachable guide catheter (outer sheath). The overall length of the assembly ranges from 190 mm to 250 mm. The outer diameter of the transfer catheter is approximately 1.4 mm and the outer diameter of the guide catheter is approximately 2.3 mm.
The catheter sets are packaged separately or assembled in an double barrier sterilisation pouch/wrapping.
All devices are sterilized using c-beam irradiation.
Trial Transfer Catheter Set
The Swemed Trial Transfer Catheter Sct is manufactured by Swemed and is identical to the Swemed Transfer Catheter Set except for tip design and packaging configuration. The differences are that the tip is closed, i.e. no hole, and that it is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only,
All devices are sterilized using e-beam irradiation.
Stylet
The Swemed stylet is manufactured by Swemed of medical grade polymers and stainless steel. The stylet consists of a handle (polyurethanc) and polymer (polytetraflourethen) covered stainless steel wire. The Swemed stylet is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only.
All devices are sterilized using e-beam irradiation.
INTENDED USE / INDICATIONS FOR USE:
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K053208
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Embryo Transfer Catheter Set
The embryo transfer catheter set is a sterile, single use device designed for in vitro fertilized (IVF) embryo transfer into the uterine cavity.
Trial Transfer Catheter Set
The trial transfer catheter is a stcrile, single use device which is designed for ensuring a free passage through the cervix prior to the embryo transfer
Stylet
The stylet is a sterile, single-use device designed to support in initial placement of the guide catheter prior to the embryo transfer.
TECHNOLOGICAL CHARACHTERISTICS
Swemed Lab International AB, believes that the subject devices are substantially equivalent to the predicate devices. The subject devices has the same intended use/indications for use, in principle the same dimensions, complies with the same standards/special controls. The differences are the sterilization method used and a minor difference in material composition.
CONCLUSION
Based on the comparison of the Swemed Clearvision™ Embryo Transfer Catheter Set and accessories to the predicate devices the conclusion is made that no new questions of safety and effectiveness are raised. Therefore, it is concluded that the requirements for substantial equivalence for the proposed devices are met.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other. The symbol is rendered in a dark color, contrasting with the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2006
Mr. Anders P. Johansson Manager for Quality Assurance & Regulatory Affairs Swemed Lab International AB Billdalsvägen 2 SE-427 36 Billdal SWEDEN
Re: K053208
Trade/Device Name: ClearVision Embryo Transfer Catheter Set, ClearVision Trial Transfer Catheter Set, and ClearVision Stylet Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: MQF Dated: November 14, 2005 Received: November 16, 2005
Dear Mr. Johansson:
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. 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 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(t) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) C)/3 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
. Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053208
KU53208
Device Name:
ClearVision Embryo Transfer Catheter Set ClearVision Trial Transfer Catheter Set ClearVision Stylet
Indications For Use:
The embr yo transfer catheter set is a sterile, single use device designed for in vitro fertilized (IVF) embr yo transfer into the uterine cavity.
The trial transfer catheter is a sterile, single use device which is designed for ensuring a free passage through the cervix prior to the embryo transfer.
The stylet is a sterile, single-use device designed to support in initial placement of the guide catheter prior to the embr yo transfer.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devic
510(k) Number K053208
Page 1 of 1
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).