(79 days)
INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination.
Instrumed gynaecological forceps are heavy forceps which have special designed jaws to hold securely without slipping during vaginal and abdominal hysterectorny procedures, yet do not lacerate the tissue to which it has been applied to even when it is necessary to exert traction.
The Instrumed gynaecological forceps are reusable surgical instruments.
To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:
- length and bending of the forceps and jaws .
- ring handles with a ratchet closure to adjust the amount of tension applied.
- jaw design, option of longitudinal grooves, teeth or cross serrations .
- the choice of jaw style depends on the surgeon's preference .
The surgeon chooses the gynaecological forceps based on the anatomy of the site and the designs desired are based on the type of the surgical procedure.
Instrumed gynaecological forceps are made of the ASTM F 899-07 standardized Stainless Steel.
The instruments are offered in non-sterile condition.
This document is a 510(k) summary for a medical device called "Instrumed Forceps Gynaecological." It's a regulatory filing to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, there is no acceptance criteria or dedicated study described that proves the device meets specific performance criteria in the way typically associated with advanced AI/Software as a Medical Device (SaMD) clearances or certain diagnostic devices.
Here's an analysis based on your requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | The document states, "The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices." |
| Not specified | "Biocompatibility review and sterilization studies were successfully completed." |
| Not specified | "The instrumed product is similar to the predicate device in terms of technical characteristics, design, Indications for Use, target population, where it is used, performance, biocompatibility, sterilization method, mechanical safety characteristics as well as sizes and configurations." |
| Not specified | "The presented data... 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." |
Explanation: This 510(k) is for a set of manual surgical instruments (gynecological forceps). For such devices, the "acceptance criteria" and "performance" are typically assessed through comparisons to predicate devices in areas like material composition, manufacturing processes, intended use, and general safety/effectiveness, rather than quantitative performance metrics like sensitivity/specificity for diagnostic AI. The document asserts comparability and successful completion of standard evaluations for surgical instruments like biocompatibility and sterilization.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This document does not describe a clinical study with a "test set" of patient data in the context of device performance in a diagnostic or AI-driven sense. The "testing" mentioned is non-clinical and bench testing of the instruments themselves.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of a "test set" requiring ground truth established by experts. The device is a manual surgical instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is not an AI/SaMD product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of diagnostic performance. For manual surgical instruments, "ground truth" relates to their physical properties, material conformity (e.g., ASTM F 899-07 standardized Stainless Steel), sterility, and ability to perform their mechanical function compared to similar devices. The document implies compliance with these standards through "non-clinical and bench testing."
8. The sample size for the training set
- Not applicable. This device is not an AI/Machine Learning model.
9. How the ground truth for the training set was established
- Not applicable.
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510(k) Summary
510(k) Summary as required by section 807.92(c)
date prepared 10/07/2009
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 Forceps Gynaecological
Common name:
Various Gynaecologic specialized manual forceps:
·
- Gynecological Forceps: Hysterectorny Clamp, Parametrium Clamp, Z-Clamp, Placenta Forceps
Classification name:
21 CFR PART 884 -- OBSTETRICAL AND GYNECOLOGICAL DEVICES Subpart E-- Obstetrical and Gynecological Surgical Devices
Sec. 884.4530 Obstetric-gynecologic specialized manual instrument. Product Code HCZ
Regulation Description
Obstetric-gynecologic specialized manual instrument/forceps
Substantial Equivalence Claims:
| HCZ | multiple FORCEPS, SURGICAL, GYNECOLOGICAL |
|---|---|
| Preamendment | Applicant AESCULAP, INC. Specification Developer |
| Preamendment | Mader Surgical Forceps; Meisterhand Surgical Forceps; Miltex Surgical Forceps;Multiple Surgical Forceps; Sparta Surgical Forceps; Vantage Surgical ForcepsApplicant MILTEX, INC. ManufacturerOwner/Operator: INTEGRA LIFESCIENCES CORPORATION |
DEC - 3 2009
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510(k)Summary
Description of the Device:
Instrumed gynaecological forceps are heavy forceps which have special designed jaws to hold securely without slipping during vaginal and abdominal hysterectorny procedures, yet do not lacerate the tissue to which it has been applied to even when it is necessary to exert traction.
The Instrumed gynaecological forceps are reusable surgical instruments.
To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:
- length and bending of the forceps and jaws .
- ring handles with a ratchet closure to adjust the amount of tension applied. �
- jaw design, option of longitudinal grooves, teeth or cross serrations .
- the choice of jaw style depends on the surgeon's preference .
The surgeon chooses the gynaecological forceps based on the anatomy of the site and the designs desired are based on the type of the surgical procedure.
Instrumed gynaecological forceps are made of the ASTM F 899-07 standardized Stainless Steel.
The instruments are offered in non-sterile condition.
Indications for Use:
INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination.
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 review and sterilization studies were successfully cry onleted.
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, sterilization method, mechanical safety characteristics as well as sizes and configurations. Therefore it can be deemed substantially equivalent for its indicated use.
Summary
The presented data that was conducted on the INSTRUMED gynaecological forceps 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DEC - 3 2009
Mr. Michael Massong QA/RA Director Instrumed International, Inc. 626 Cooper Court SCHAUMBURG IL 60173
Re: K092840
Trade/Device Name: Instrumed Forceps Gynaecological Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HCZ Dated: November 10, 2009 Received: November 10, 2009
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.
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 (reporting of medical
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device-related 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
| 510(k) Number (if known): | K09 2840 |
|---|---|
| Device Name: | Instrumed Forceps Gynaecological |
| Indications For Use: | INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination. |
| 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)
Hulst Rums
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
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§ 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.