(833 days)
Not Found
No
The device description details a purely mechanical device for intrauterine insemination, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way," which describes a medical condition. The "Device Description" explains that the device "functions as a means of accurately injecting the sperm into the uterus of the receptor patient." This directly addresses a medical condition (infertility) and aims to restore fertility, which is a therapeutic purpose.
No
Explanation: The device description clearly states its function is "accurately injecting the sperm into the uterus of the receptor patient." It is an insemination device, not one used for diagnosis.
No
The device description clearly outlines physical components made of polyurethane, polyvinyl chloride, and polypropylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device 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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ackrad IUI Set is a medical device used to physically introduce sperm into the uterus. It is a tool for a medical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is to assist in achieving pregnancy by facilitating intrauterine insemination, which is a procedural intervention.
- Device Description: The description details physical components for insertion and delivery, not reagents or equipment for analyzing biological samples.
Therefore, the Ackrad IUI Set falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Ackrad IUI Set is intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way.
Product codes
Not Found
Device Description
The Ackrad IUI Set consists of two parts: a calibrating probe and an introducing catheter, each of which is accompanied by a placement sheath to aid in insertion.
The calibrating probe is a clear flexible tube, closed and rounded at the distal tip. A movable stop is attached to assist in calibrating the depth of Five narrow bands, one cm apart, designate insertion. distances of 25, 26, 27, 28 and 29cm from the distal tip, with a wide band at 30cm from the tip. lyne proximal end is fitted with a two-cm length of large The outside diameter tubing to serve as a handle. diameter of the probe is 1.8 mm and the working length is 44.0 cm.
The introducing catheter is identical to the calibrating probe except that the distal end has an end port or side port within 3 mm of the tip, and the proximal end is fitted with a standard female luer-lock hub.
Both the probe and the catheter are composed of clear, naturally flexible polyurethane material. The movable stop is composed of clear polyvinyl chloride of a 55-60A durometer.
Both the calibration probe and the catheter have a placement sheath through which they pass as an aid in The sheath is composed of rigid insertion. polypropylene material, 20 cm long with an inside diameter of 3.4 mm and an outside diameter of 4.6 mm. The distal end is rounded to minimize trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, cervix
Indicated Patient Age Range
25 to 45 (for the patient population description) and 24 to 42 (for clinical testing)
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)
Non-clinical tests:
Pull tests were conducted on the attachments of the proximal fittings of the probe and catheter. Five samples were tested, all samples resisted a force of 1 kg .
Ten samples were wiped over the banded area with a paper wipe soaked in warm water. No smearing or removal of the black markings was observed.
Laboratory tests:
Prior to introducing the catheter into clinical testing studies were performed in which sperm were loaded into the catheter and incubated at 37℃ overnight. Sperm motility as determined the next morning was not different from that of control sperm not incubated in the catheter.
Clinical testing:
The IUI Set was used at the Reproductive Endocrinology and Fertility Services department of The Malden Hospital (100 Hospital Road, Malden, MA 02148) for intrauterine insemination procedures on female patients between the ages of 24 to 42 under informed consent conditions. None of the patients experienced adverse affects and no complication occurred.
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
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).
0
长940176
510 (K) Summary
REQUIRED INFORMATION A.
- Submitted by: Ackrad Laboratories, Inc. 70 Jackson 1. Drive, Cranford, NJ 07016. Telephone number (908) 276-Contact person: Bernard Ackerman, Ph.D. 6390. Date: December 28, 1993
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- Device name Ackrad IUI Set for Intrauterine Insemination
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- Predicate devices
- Description of the device 4 . The Ackrad IUI Set consists of two parts: a calibrating probe and an introducing catheter, each of which is accompanied by a placement sheath to aid in insertion. (Exhibit 1)
The calibrating probe is a clear flexible tube, closed and rounded at the distal tip. A movable stop is attached to assist in calibrating the depth of Five narrow bands, one cm apart, designate insertion. distances of 25, 26, 27, 28 and 29cm from the distal tip, with a wide band at 30cm from the tip. lyne proximal end is fitted with a two-cm length of large The outside diameter tubing to serve as a handle. diameter of the probe is 1.8 mm and the working length is 44.0 cm.
The introducing catheter is identical to the calibrating probe except that the distal end has an end port or side port within 3 mm of the tip, and the proximal end is fitted with a standard female luer-lock hub.
Both the probe and the catheter are composed of clear, naturally flexible polyurethane material. The movable stop is composed of clear polyvinyl chloride of a 55-60A durometer.
Both the calibration probe and the catheter have a placement sheath through which they pass as an aid in The sheath is composed of rigid insertion. polypropylene material, 20 cm long with an inside diameter of 3.4 mm and an outside diameter of 4.6 mm. The distal end is rounded to minimize trauma.
1
-52-
The ink used for the banding of the catheter and probe is No-tox no. M-1000, manufactured by the Colorcon Corp. of West Point, PA.
The device functions as a means of accurately injecting the device ranodens the uterus of the receptor patient. The calibrating probe is first used to measure the Then sperm is introduced proper depth for insertion. into the uterus via the catheter and expelled at the the placement sheath allows both the proper depth. probe and the catheter to be advanced through the cervix of the patient easily and non-traumatically without buckling or inadvertently touching the vagina.
- Intended Use 5.
The Ackrad IUI Set is intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way. The patient population comprises women generally ranging in age from 25 to 45.
The intended use is the same as the Royal Women's Coaxial Catheter Set (i.e. intrauterine insemination). The intended use is different from the Ackrad H/S Catheter Set which is used for a diagnostic procedure, hysterosalpingography. The H/S Catheter is passed into the uterus and delivers a quantity of contrast media for x-ray or ultrasound diagnosis. The IUI probe and catheter are passed into the uterus in exactly the same way, using the same placement sheath as the H/S Catheter way, abing the sperm into the uterus upon depression of an external syringe.
- Technological Characteristics 6.
The materials of the IUI set are virtually identical to those of the H/S Catheter. The only difference is that the polyurethane tubing of the H/S Catheter contains a radiopaque ingredient, while the identical polyurethane tubing of the IUI catheter and probe contains no The placement sheath is additive and is clear. Both the marking ink and identical in both devices. movable stop are FDA-approved materials and in any case do not contact body tissue during the procedure.
The Ackrad IUI Set is similar to the Royal Women's Coaxial Catheter set but differs in that the former is used in two separate insertions. The IUI Set differs from the H/S Catheter Set in that both the probe and catheter of the former have no balloon and the catheter In addition, the IUI Set is single, not double lumen. has marking bands ascribed to assess the depth of insertion, and is optically and radiographically transparent.
2
PERFORMANCE DATA B.
- Non-clinical tests 1.
Pull tests were conducted on the attachments of the proximal fittings of the probe and catheter. Five samples were tested, all samples resisted a force of 1 kg .
Ten samples were wiped over the banded area with a paper No smearing or removal of wipe soaked in warm water. the black markings was observed.
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2 . Laboratory tests
Prior to introducing the catheter into clinical testing studies were performed in which sperm were loaded into the catheter and incubated at 37℃ overnight. Spern motility as determined the next morning was not different from that of control sperm not incubated in the catheter. -
Clinical testing 3.
The IUI Set was used at the Reproductive Endocrinology and Fertility Services department of The Malden Hospital (100 Hospital Road, Malden, MA 02148) for intrauterine insemination procedures on female patients between the ages of 24 to 42 under informed consent conditions (see None of the patients experienced adverse Exhibit 4). affects and no complication occurred.
C. CONCLUSIONS OF SAFETY AND EFFECTIVENESS The Ackrad IUI set is a safe and effective device for achieving pregnancy following intrauterine insemination. It has an advantage over existing devices in that it affords flexibility and ease of insertion in to the uterus.
Ψ
3
Image /page/3/Figure/0 description: The image contains the text '510(K) ACKRAD IUI SET Exhibit 1'. The text is oriented vertically and appears to be part of a document or exhibit label. The background is plain, with some minor artifacts or markings present.
Image /page/3/Figure/1 description: The image shows a diagram of an introducing catheter with a side port. The catheter is long and thin, with a connector at one end and a side port near the other end. The side port is a small opening in the side of the catheter that allows for the introduction of fluids or other substances. The catheter is used to introduce other medical devices into the body.
นุวยอนุร วันอนลวย เส
. •
:
Image /page/3/Figure/3 description: The image shows a diagram of a calibrating probe with a movable stop. The probe has a long, thin body with markings along its length. The movable stop is positioned along the body of the probe. The probe terminates in a circular end with a marked section.
4
510(K) ACKRAD IUI SET Exhibit 2
ROYAL WOMEN'S COAXIAL CATHETER SETS
The translucent inner cathered to fit coaxially through the larger diemeter introducing catheter. Centimater markings on the proximal portion of the inner cather of to distal tip relative to the of the introducing catheler. The introducing catherer is of a two-part design with an inner translucent skeeve axtending 4 cantimeters beyond the larger diameter portion. The inner catheter is aveilable with either an open-end, or closed-and with side opening. Supplied sterile in peel-open packages.
Image /page/4/Figure/4 description: The image shows diagrams of different types of catheters and a table describing the set order number and remarks for each catheter. The first catheter is an introducing catheter with an 8.5 French radiopaque Teflon and an 8.5 French translucent Teflon tip. The second catheter is an open-end inner catheter that is 3.0 French translucent Teflon and 28 cm long, and the third catheter is a side opening inner catheter that is translucent Teflon. The table lists the set order numbers KJLLS-882100, KJLLS-882101, KJLLS-882102, and KJLLS-882103, along with their corresponding remarks, which describe the type of inner catheter and fittings.
nefenence
I. W. H. Johnston, M.D., A. Lopeta, M.D., P. Laung, M.D., Repreductive Blokeyy Unit, Royal Wornen's Hospitalia, Australia,
QOOK OB/GYN® A DIVISION OF COOK UROLOGICAL INC. 1 100 West Morgen Street P.O. Bax 27 1 Spencer, Indiane 47460 U.S.A. Phone: 812 829-6500 Telefax: 812 829 2022 Toll Free: 800 541-5591 Telex: 8711525
· COPYRIGHT COOK UROLOGICAL INCORPORATED 1989
- COOK OB/GYN°—
K.J.L.S. DDS