(127 days)
No
The device description focuses on the physical characteristics and function of aspiration needles, with no mention of AI or ML technologies.
No
The device is used to obtain gametes from the body through aspiration, which is a diagnostic or procedural function, not a therapeutic one. It facilitates a medical procedure rather than treating a disease or condition.
No
The device is used to obtain gametes (oocytes) from ovarian follicles by aspiration and/or flushing. This is an interventional procedure, not a diagnostic one. While it uses ultrasound for guidance, its primary function is retrieval of biological material rather than identifying a medical condition or disease.
No
The device description clearly details physical components such as needles, lumens, and protective tubes, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This examination is performed outside of the body (in vitro).
- Device Function: The Swemed Follicle Aspiration Sets are used to obtain gametes (oocytes) from the body. They are a tool for a medical procedure (follicle aspiration), not for analyzing a specimen after it has been collected.
- Intended Use: The intended use is to "obtain gametes from the body" and for "flushing and/or aspiration of oocytes from ovarian follicles." This describes a procedure performed on the patient, not an analysis of a sample.
While the collected oocytes might be used in subsequent in vitro procedures (like IVF), the aspiration set itself is a surgical/procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Swemed Follicle Aspiration Sets are intended to be used to obtain gametes from the body. The Swemed Follicle Aspiration Sets are indicated for use in flushing and/or aspiration of oocytes from ovarian follicles.
Product codes
85 MQE
Device Description
The Swemed Follicle Aspiration Sets are designed with either a single lumen which is capable for aspiration from the follicle or a double lumen which is capable of aspiration and flushing of sterile medium through the outer lumen up to the follicle. The needle has a beveled tip provided with shallow grooves to improve ultrasound image enhancement. The needle are supplied with a protective tube on the tip, which must be removed before use. The needles have inner diameters of 0.8 - 1.2 mm and outer diameters of 1.47 - 1.65 mm, which approximates a 16 and 17 gauge needle, respectively. The needle length ranges from 25 to 35 cm. The set is packed in an inner and outer wrapping, and steam sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
ovarian follicles
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
0
AUG 18 1999
pg 1 of 2
K99/273
Attachment 15
510(k) SUMMARY Swemed's Follicle Aspiration Set
Submitter's Name, Address, Telephone Number, Contact Person
Scan-Med, Inc. as U.S. distributor for Swemed Lab International AB Post Office Box 128 Middle Grove, New York 12850 or Telephone: (800) 722-6016 Facsimile: (888) 722-6633
Edward C. Wilson, Jr., Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Telephone: (202) 637-5839 Facsimile: (202) 637-5910
Date Prepared: April 13, 1999
Name of Device and Name/Address of Sponsor
Swemed Follicle Aspiration Sets, Double Lumen, Single Lumen, and Luer Needle
Scan-Med, Inc. as U.S. distributor for Swemed Lab International AB Post Office Box 128 Middle Grove, New York 12850 (800) 722-6016 Telephone: (800) 722-6016 Facsimile: (888) 722-6633
Common or Usual Name
Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle
Classification Name
Assisted Reproduction Needles
Predicate Devices
Cook OB/GYN Ovum Pick-Up Aspiration Needles, Single Lumen and Double Lumen
Swemed Needle For Amniocentesis And Cyst Puncture
Intended Use
The Swemed Follicle Aspiration Sets are intended to be used to obtain gametes from the body.
1
K99/273
pg 2 of 2
Indications for Use
The Swemed Follicle Aspiration Sets are indicated for use in flushing and/or aspiration of oocytes from ovarian follicles.
Technological Characteristics
The Swemed Follicle Aspiration Sets are designed with either a single lumen which is capable for aspiration from the follicle or a double lumen which is capable of aspiration and flushing of sterile medium through the outer lumen up to the follicle. The needle has a beveled tip provided with shallow grooves to improve ultrasound image enhancement. The needle are supplied with a protective tube on the tip, which must be removed before use. The needles have inner diameters of 0.8 - 1.2 mm and outer diameters of 1.47 - 1.65 mm, which approximates a 16 and 17 gauge needle, respectively. The needle length ranges from 25 to 35 cm. The set is packed in an inner and outer wrapping, and steam sterilized.
Basis for Substantial Equivalence
The Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles share the exact same intended use: to obtain oocytes from the body and the exact same indication for use: flushing and/or aspiration oocytes from ovarian follicles. Except for four minor features, the Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Needles are nearly identical. The only differences between the Swemed Follicle Aspiration Sets and the Cook Ovum Pick-Up Aspiration Needles are that (1) the needles on the Swemed Follicle Aspiration Sets has a 13-15° bevel and the Cook Ovum Pick-Up Needles have a 60° bevel; (2) the inside and outside diameters are slightly different; and (3) the Swemed Follicle Aspiration Sets include a set of five Falcon tubes for aspirate collection whereas the Cook Ovum Pick-Up Needles do not provide the Falcon tubes, but rather recommend the use of Falcon tubes for aspirate collection: and (4) Swemed supplies PVC tubing to facilitate connection of the Follicle Aspiration Set to an aspiration pump. T These minor differences do not affect the safety or effectiveness of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
Swemed Lab International AB c/o Mr. Edward C. Wilson, Jr., Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K991273
Swemed Lab International AB's Follicle Aspiration Set. Double Lumen. Single Lumen, and Luer Dated: August 5, 1999 Received: August 5, 1999 Regulatory Class: II 21 CFR §884.6100/Procode: 85 MQE
Dear Mr. Wilson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) 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 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 17
510(k) Number (if known): K991273
Swemed Follicle Aspiration Set, Double Lumen, Device Name: Swemed Follicle Aspiration Set, Single Lumen, and Swemed Follicle Aspiration Luer Needle
Indications for Use:
The Swemed Follicle Aspiration Set, Double Lumen: Swemed Follicle Aspiration Set, Single Lumen; and Swemed Follicle Aspiration Luer Needle and intended to obtain gametes from the body and are specifically indicated for flushing and/or aspiration of oocytes from ovarian follicles.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_
Thind C. Sazman
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number
(Optional Format 1-2-96)