(315 days)
The Atad Pre-Induction Cervical Dilator is indicated for mechanical dilation of the cervical canal prior to labor induction a term when the cervix is unfavorable for induction.
The Atad Dilator is an 18Fr, 400mm, natural latex, three-lumen, double latex balloon catheter with a corresponding valve for each balloon and a disabled third lumen that is not intended to be used.
Acceptance Criteria and Device Performance Study for the Atad Pre-Induction Cervical Dilator
Based on the provided 510(k) summary (K040625), the Atad Pre-Induction Cervical Dilator is a medical device for cervical dilation. The provided documentation does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (Quality Medical Solutions, LLC Laminaria Cervical Dilator, K021012), primarily through a comparison of technological characteristics and clinical performance.
The "acceptance criteria" can be inferred from the comparative table and the stated conclusion of "substantial equivalence" to the predicate device. The study aims to show that the Atad Dilator is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not provided, the table below infers "acceptance criteria" as the comparable performance to the predicate device and lists the reported performance of the Atad Dilator.
| Feature / Acceptance Criteria (Inferred from Predicate) | Reported Atad Dilator Performance |
|---|---|
| Lithotomy position & vaginal speculum for insertion | Yes |
| Insertion through cervical external os | Yes |
| Prevention of cervical tears and fistula | Yes |
| Gradual dilation of the cervix | Yes |
| No higher incidence of preterm labor or late abortions | True |
| Time required to achieve dilation: 6-24 hrs (Laminaria) | 6-12 hrs |
| Effectiveness of the method: Comparable to Laminaria | Comparable |
| Safety: Comparable to Laminaria | Comparable |
| Mean insertion to delivery time (Hours): 6-23 (Laminaria) | 19-25 |
| Cesarean delivery range (%): 20%-40% (Laminaria) | 13%-28% |
| Increased risk to the outcome of pregnancy: None | None |
| Vaginal packing required to avoid expulsion/displacement: Required (Laminaria) | Not required |
| Difficulties in removal: Possible (Laminaria) | Not recorded |
| Need of lithotomy and vaginal speculum for removal: Needed (Laminaria) | No need |
Note: The reported performance of the Atad Dilator meets or in some cases exceeds (e.g., shorter required dilation time, lower Cesarean delivery range, no packing needed) the characteristics of the predicate device, supporting substantial equivalence.
2. Sample Size and Data Provenance for the Test Set
The document states: "The safety and effectiveness of the Atad Dilator for cervical dilation prior to labor induction in women at term has been demonstrated in several clinical trials."
- Sample Size Used for the Test Set: The specific sample sizes for the "several clinical trials" are not provided in this 510(k) summary.
- Data Provenance: The country of origin of the data is not explicitly stated. Given the submitter's address (Haifa, Israel), it is plausible that some or all of the clinical trials were conducted in Israel, but this is not confirmed in the document. The data is prospective, as it comes from clinical trials demonstrating safety and effectiveness.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials mentioned. Clinical trials typically involve medical professionals (doctors, nurses) for patient management and data collection, but the role of specific "experts" for ground truth adjudication (as might be seen in imaging studies) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the data collected in the clinical trials. Clinical trial data collection involves standard medical procedures and possibly independent monitoring, but a formal adjudication process for "ground truth" in the context of diagnostic device assessment is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The Atad Pre-Induction Cervical Dilator is a medical device (a catheter for mechanical dilation), not an imaging or diagnostic AI device. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not applicable to this type of product.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) study was not done. This device is a physical medical instrument (a catheter) that functions through mechanical dilation, not an algorithm. Therefore, an "algorithm only" performance study is not applicable. Its performance is evaluated through its physical interaction with the human body in a clinical setting.
7. Type of Ground Truth Used
The ground truth for the clinical trials would have been established through direct clinical observation and measurement of outcomes. This includes:
- Clinical Measurements: Cervical dilation (e.g., in centimeters or Bishop score changes).
- Patient Outcomes: Time to delivery, mode of delivery (vaginal vs. Cesarean), incidence of preterm labor, late abortions, complications (cervical tears, infection), and ease of device insertion/removal.
- Clinical Assessment: Physicians' assessments of safety and effectiveness.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such devices typically refers to engineering design, material selection, and manufacturing process optimization, which are not based on data sets in the same way an AI model is.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device does not have a "training set" in the context of AI/ML. The "ground truth" in its development would refer to engineering specifications, material properties, and preclinical testing results (e.g., burst pressure, flow rate testing as mentioned in the summary) compared against established standards for medical devices.
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JAN 1 8 2005
510(K) SUMMARY
1. Submitter Name, Address, and Date of Submission:
Dr. Jack Atad Director Atad Developments and Medical Services Ltd. 70 Yakinton St. Ramat Almogi Haifa 34792, Israel
Telephone Number: (972) 48243342
Fax Number: (972) 48242662
E-Mail: atadjack(a)zahav.net.il
Contact: Same as above
Name of the Device, Common, Proprietary (if known), and Classification: 2.
Classification Name: Hygroscopic Laminaria cervical dilator (21 C.F.R. § 884.4260)
Common Name: Cervical dilator Proprietary Name: Atad Pre-Induction Cervical Dilator
3. Identification of the legally marketed device to which the submitter claims equivalence:
The Atad Pre-Induction Cervical Dilator) is substantially equivalent to the Quality Medical Solutions, LLC Laminaria Cervical Dilator, K021012, and other legally marketable laminaria indicated for cervical dilation.
4. Description of Device:
The Atad Dilator is an 18Fr, 400mm, natural latex, three-lumen, double latex balloon catheter with a corresponding valve for each balloon and a disabled third lumen that is not intended to be used.
5. Intended Use of the Device:
The Atad Dilator is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.
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Summary of Technological Characteristics: 6.
The Atad Dilator produces cervical dilation by the internal instillation of water in controlled spaces at the ends of the cervical canal. It is introduced through the lumen and expands the internal balloons. The operation is similar to laminaria which similarly expand internally within the canal through the absorption of water. The technological characteristics differ from those of a laminaria in terms of design, material and performance "mechanics." However, the design, materials and performance "mechanics" are comparable to marketed catheters and cannulas used for other purposes but which have exposure to the same body parts and locations. In particular, the Atad Dilator is comparable to the COOK Balloon Cannula and the COOK Double Balloon Hysterosalpingography Catheter (K890869).
The Atad Dilator, as with the laminaria, is inserted through the cervical canal and pressure is applied on the cervix by water-filled balloons inflated at the extremities of the cervix. This gradually will dilate the cervix in a period of approximately 6-12 hours. The predicate device laminaria is inserted through the cervical canal and is kept in place approximately 6-24 hours. By its hygroscopic capability, the expanded laminaria applies a gradual pressure on the cervix to effect its dilation. The Atad Dilator is inflated with 80 mL of sterile water or saline in each balloon. Following inflation of the two balloons positioned at the extremities of the cervix, pressure is applied on the cervix. The pressure applied by the balloons on the extremities of the cervix will dilate the cervix. Clinical trials support this effect in both the Atad Dilator and its predicate device, the laminaria. Cervical dilation of 3-4 cm occurs with the Atad Dilator.
| FEATURE | ATADDILATOR | LAMINARIA |
|---|---|---|
| Lithotomy position and insertion of a vaginal speculum in order toexpose the cervix for the insertion of the Atad Dilator or laminaria: | Yes | Yes |
| Insertion through the cervical external os: | Yes | Yes |
| Prevention of cervical tears and fistula by gradual pressure on thecervix : | Yes | Yes |
| Gradual dilation of the cervix as a result of the pressure applied bythe dilating mechanism: | Yes | Yes |
| No higher incidence of preterm labor or late abortions following theprocedure: | True | True |
| Time required to achieve dilation: | 6-12 hrs. | 6-24 hrs. |
| Effectiveness of the method: | Comparable | Comparable |
| Safety: | Comparable | Comparable |
| Mean insertion to delivery time (Hours): | 19-25 | 6-23 |
| Cesarean delivery range (%): | 13% -28% | 20% - 40% |
| Increased risk to the outcome of pregnancy | None | None |
| Vaginal packing required to avoid expulsion and displacement | Not required | Required |
| Difficulties in removal of the laminaria or the Atad Dilator | Not recorded | Possible |
| Need of lithotomy and vaginal speculum insertion for removal | No need | Needed |
Below is a table comparing the Atad Dilator atheter to the predicate laminaria:
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7. Summary of Non-Clinical and Clinical Tests and How Results Support Substantial Equivalence
The Atad Dilator has been subjected to all appropriate biocompatibility and performance testing including burst, pressure and flow rate testing. The device was found acceptable in all non-clinical testing phases. The safety and effectiveness of the Atad Dilator for cervical dilation prior to labor induction in women at term has been demonstrated in several clinical trials.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2005
Atad Developments and Medical Services Ltd. c/o Mr. Neil F. O'Flaherty Olsson, Frank and Weeda, P.C. 1400 Sixteenth Street, NW, Suite 400 WASHINGTON D.C. 20036
Re: K040625 Trade/Device Name: Atad Pre-Induction Cervical Dilator Regulation Number: 21 CFR 884.4260 Regulation Name: Hygroscopic-laminaria cervical dilator Regulatory Class: II Product Code: 85 HDY Dated: October 20, 2004 Received: October 20, 2004
Dear Mr. O'Flaherty:
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 (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. 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 electronic 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(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), 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" (21 CFR 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/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
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): K040625
| Device Name: | Atad Pre-Induction Cervical Dilator |
|---|---|
| Indications for Use: | The Atad Pre-Induction Cervical Dilator is indicated formechanical dilation of the cervical canal prior to labor induction aterm when the cervix is unfavorable for induction. |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
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§ 884.4260 Hygroscopic Laminaria cervical dilator.
(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).