(38 days)
Not Found
Not Found
No
The device description explicitly states it is a "common and same type, traditional device" and makes no mention of AI or ML.
No
The device, 'EosSmear', is described as an Ayer's spatula type used for scraping and removing cytological material from the cervix or vagina for Pap tests. Its purpose is for diagnosis/screening, not for treating a condition, and it closely resembles existing diagnostic tools for Pap tests. It's intended to collect samples, not to provide therapy.
No
The device is described as an Ayer's spatula type, used for scraping and removing cytological material from the cervix or vagina for Pap smears. Its function is to collect samples, not to perform analysis or interpretation of those samples to diagnose a condition.
No
The device description explicitly states it is a physical "Ayer's spatula type" made of wooden or plastic materials, which is a hardware component.
Based on the provided text, the device described is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device description: The device, EosSmear, is described as an Ayer's spatula type used for scraping and removing cytological material from the surface of the cervix or vagina. This is a tool used for collecting a sample from the body.
- Intended Use: The intended use is for Pap smears, which involve collecting cells from the cervix for subsequent laboratory analysis. The device itself is the collection tool, not the diagnostic test performed on the collected sample.
While the collected sample is used for an in vitro diagnostic test (the Pap smear analysis in a lab), the device itself is a medical device used for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
The device has the same intended use and technological characteristics as the legally premarketed devices. Its usage, mode of action are equivalent to the legally premarketed devices.
And our this device is the same purpose used for Pap.s.as the premarketed devices which we mentioned as followings;
Product codes
Not Found
Device Description
The device-EosSmear is the Ayer's spatula type with screw round top for easily scraping and removing the cytological material from the surface of the cervix or vagina; and the back of the design is for scraping also of the cervical area and SCJ part of the body.
The device is not a special or very new device, but a common and same type , traditional device that used for Pap. s.. As in the world the spatula is not a special one, people supply the same-premarketed devices as Ayer's spatula in wooden or plastic materials, or Cyto-brush types but with their own brand name , so as the EosSmear is the same usage, intended use, same safety and effectiveness for which is the substantial equivalence to the premarketed devices disposable,low cost and light weight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix or vagina, cervical area and SCJ part of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctors, nurses, medical traders purchasers of the medical products, etc., they are commonly used in the nospitals for Pap.s.
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
material test which shows non-heavy metal contents of our device,; and the sterility test proves the device is safe and hygiene , no harm to patients due to the sterilization by GAMMA Radiation is approved.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
OCT 11 1996
Image /page/0/Picture/1 description: The image shows a logo with the letters "EUS" in white against a black background. The letters are stylized and connected, with horizontal lines running above and below them. To the right of the "S", there is a star-like shape with a tail extending upwards, adding a dynamic element to the logo.
NORTH EOS INDUSTRIES, INC.
54, LANE 1, BEEN STREET, P.O.BOX 22 K963685 TUNG SHIH, TAICHUNG HSIEN 423 TAIWAN, R.O.C. FAX : +886 4 5887000 TELEPHONE : +886 4 5875000
Classification ; EOS Brand Disposable Cyto/Cervical Sampler Common name and ; EosSmear Brand name ; EOS Brand Registration ; #8043235 Class I
DATE : AUG.28,1996 REF. :
510(k) SUMMARY 제 2000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000000000000000000000000000000000
l'he device has the same intended use and technological characteristics as the legally premarketed devices. Its usage, mode of action are equivalent to the legally premarketed devices.
se indicate devices that premarketed world widely, the devices also called by people among medical fields , like, doctors, nurses, medical traders purchasers of the medical products, etc., they are commonly used in the nospitals for Pap.s.,
And our this device is the same purpose used for Pap.s.as the premarketed devices which we mentioned as followings;
Ayer's spatula (wooden) , made in many countries the same type Ayer's spatula (plastic) Cyto-Brush made in U.K. cervi-brush . 【【 Endocervical sampler also supplied by countries. Cotton Swab CycoPick Japan Grnoscain Portugal Spatulas and cotton Swabs Germany (Paul Boettger ong company) Cyto-spatula for cervical smear made in Switzerland
The device-EosSmear is the Ayer's spatula type with screw round top for easily scraping and removing the cytological material from the surface of the cervix or vagina; and the back of the design is for scraping also of the cervical area and SCJ part of the body.
The device is not a special or very new device, but a common and same type , traditional device that used for Pap. s.. As in the world the spatula is not a special one, people supply the same-premarketed devices as Ayer's spatula in wooden or plastic materials, or Cyto-brush types but with their own brand name , so as the EosSmear is the same usage, intended use, same safety and effectiveness for which is the substantial equivalence to the premarketed devices disposable,low cost and light weight.
The cervical spatula, some doctors used with sterilized, or non-sterilized. As it touches the body surface at very short time, so we made tests of material test which shows non-heavy metal contents of our device,; and the sterility test proves the device is safe and hygiene , no harm to patients due to the sterilization by GAMMA Radiation is approved.