(65 days)
INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage - · suspicion of immediate or potential fetal compromise - · shortening of the second stage for maternal benefit
Instrumed obstetrical forceps are instruments designed to aid in the delivery of the fetus. Many different types of forceps have been described and developed. Generally, forceps consist of 2 mirror image metal instruments that are manoeuvred to cradle the fetal head and are articulated, after which traction is applied to effect delivery. Forceps have 4 major components, as follows: - Blades: The blades grasp the fetus. Each blade has a curve to fit around the fetal head. The . blades are oval or elliptical and can be fenestrated (with a hole in the middle) or solid. Many blades are also curved in a plane 90° from the cephalic curve to fit the maternal pelvic curve). - Shanks: The shanks connect the blades to the handles and provide the length of the device. They . are either parallel or crossing. - Lock: The lock is the articulation between the shanks. Many different types have been designed. . - Handles: The handles are where the operator holds the device and applies traction to the fetal . head. The surgeon chooses the obstetrical/gynaecological forceps based on the anatomy of the site and the type desired, based on the type of the surgical procedure. Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel. The instruments are offered in non-sterile condition.
The provided text describes a 510(k) submission for Instrumed Obstetrical Forceps. It details the device's description, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the content provided, the acceptance criteria and the study proving the device meets them are articulated in terms of equivalence to predicate devices, rather than specific performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device Equivalence) | Reported Device Performance |
|---|---|---|
| Technical Characteristics | Comparable to predicate devices (TEKNO-MEDICAL OBSTETRICAL FORCEPS K013747, V. MUELLER OBSTETRICAL (OB) FORCEPS K951529) | "The Instrumed product is similar to the predicate device in terms of technical characteristics, design..." |
| Design | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of technical characteristics, design..." |
| Indications for Use | Identical or substantially similar to predicate devices | Identical indications for use: "to grasp and apply traction to the fetal head to facilitate delivery for... prolonged second stage, suspicion of immediate or potential fetal compromise, shortening of the second stage for maternal benefit." |
| Target Population | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... Target population..." |
| Usage Environment | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... where it is used..." |
| Performance | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... performance..." |
| Biocompatibility | Acceptable in comparison to predicate devices | "Biocompatibility and sterilization studies were successfully completed." "The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product." |
| Sterilization Method | Acceptable in comparison to predicate devices | "The Instrumed product is similar to the predicate device in terms of... sterilisation method..." (Offered in non-sterile condition, implying sterilization by the user is required/expected, similar to predicate). |
| Mechanical Safety | Comparable to predicate devices | "The Instrumed product is similar to the predicate device in terms of... mechanical safety characteristics..." |
| Materials | ASTM F 899-09 standardized Stainless Steel, deemed safe and effective | "Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel." "The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product." |
| New Safety/Effectiveness Questions | No new questions regarding safety or effectiveness should be raised. | "The presented data that was conducted on the Instruments shows... that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or data provenance in the context of clinical studies with human participants. The evaluation relies on non-clinical and bench testing to demonstrate similarity to predicate devices. Therefore, traditional "sample size" for a clinical test set is not applicable here.
- Sample Size for Test Set: Not applicable as no human clinical test set is described. The evaluation is primarily based on non-clinical and bench testing of the device itself and comparison to predicate devices.
- Data Provenance: Not explicitly stated as the evaluation focuses on the physical device and its properties, materials, and design in comparison to existing devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given that the submission is for substantial equivalence based on non-clinical and bench testing and comparison to predicate devices, there's no mention of a ground truth established by medical experts for a test set of patient data.
4. Adjudication Method for the Test Set
This information is not provided in the document. As no human clinical test set requiring expert ground truth or adjudication is described, this section is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The device is a surgical instrument (forceps), and its evaluation is based on material properties, design, and functional similarity to already marketed predicate devices, not on the interpretation of medical images by multiple readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a manual surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator (the surgeon).
7. The Type of Ground Truth Used
The "ground truth" in this context is implicitly established by the known safety and effectiveness of the predicate devices and the standards for material properties (e.g., ASTM F 899-09 for stainless steel). The claim is that the Instrumed Obstetrical Forceps functions equivalently to these well-established devices and uses appropriate materials, thus achieving safety and effectiveness.
- Implicit Ground Truth: Safety and effectiveness of legally marketed predicate devices and compliance with material standards.
8. The Sample Size for the Training Set
This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set" or its associated ground truth establishment.
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510(k) Summary as required by section 807.92(c)
date prepared 04/26/2010
Submission Applicant:
INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
Establishment Registration Number:
1421101
Official Correspondent:
Mr. Berndt Fetzer INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
Phone: 847-908-0292
Trade name:
Instrumed Obstetrical Forceps .
Common name:
Various Obstetric-Gynaecologic specialized manual instruments/Obstetrical Forceps:
Simpson, Wrigley, Elliott, De Lee, Luikart Simpson, Piper, McLean-Luikart, Mclean-Tucker-Luikart, Boerma, Naegele
Classification name:
-- OBSTETRICAL AND GYNECOLOGICAL DEVICES 21 CFR PART 884 Subpart E--Obstetrical and Gynecological Surgical Devices
Sec. 884.4400 Obstetric forceps. Product Code HDA
Regulation Description
Obstetric-gynecologic specialized manual instrument/forceps
Substantial Equivalence Claims:
- HDA TEKNO-MEDICAL OBSTETRICAL FORCEPS K013747 Applicant TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO.
V. MUELLER OBSTETRICAL (OB) FORCEPS K951529 Applicant BAXTER HEALTHCARE CORP.
K100517
APR 2 9 2010
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Description of the Device:
Instrumed obstetrical forceps are instruments designed to aid in the delivery of the fetus. Many different types of forceps have been described and developed. Generally, forceps consist of 2 mirror image metal instruments that are manoeuvred to cradle the fetal head and are articulated, after which traction is applied to effect delivery.
Forceps have 4 major components, as follows:
- Blades: The blades grasp the fetus. Each blade has a curve to fit around the fetal head. The . blades are oval or elliptical and can be fenestrated (with a hole in the middle) or solid. Many blades are also curved in a plane 90° from the cephalic curve to fit the maternal pelvic curve).
- Shanks: The shanks connect the blades to the handles and provide the length of the device. They . are either parallel or crossing.
- Lock: The lock is the articulation between the shanks. Many different types have been designed. .
- Handles: The handles are where the operator holds the device and applies traction to the fetal . head.
The surgeon chooses the obstetrical/gynaecological forceps based on the anatomy of the site and the type desired, based on the type of the surgical procedure.
Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel. The instruments are offered in non-sterile condition.
Indications for Use:
INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage
- · suspicion of immediate or potential fetal compromise
- · shortening of the second stage for maternal benefit
Comparison with Predicate Device:
The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed.
The Instrumed product is similiar to the predicate device in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics as well as sizes and configurations. Therefore it can be deemed substantially equivalent and safe and effective for its indicated use.
Summary
The presented data that was conducted on the Instruments shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael Massong RA/QA Director Instrumed International, Inc. 626 Cooper Court SCHAUMBURG IL 60173
APR 2 9 2010
Re: K100517
Trade/Device Name: Instrumed Obstetrical Forceps Regulation Number: 21 CFR 8884.4400 Regulation Name: Obstetric forceps Regulatory Class: II Product Code: HDA Dated: February 16, 2010 Received: February 23, 2010
Dear Mr. Massong:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
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Page 2 -
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting 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
KI00517 510(k) Number (if known):
Device Name:
Instrumed Obstetrical Forceps
Indications For Use:
INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina:
- · prolonged second stage
- · suspicion of immediate or potential fetal compromise
- · shortening of the second stage for maternal benefit
Prescription Use
(Part 21 CFR 801 Subpart D) X 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)
Sh. L. Nolan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K100517 510(k) Number
Page 1 of 1
§ 884.4400 Obstetric forceps.
(a)
Identification. An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.