(101 days)
Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
Integra® Gynecological Surgical Forceps are designed to provide a secure grip on tissue during vaginal and abdominal hysterectomy procedures. These atraumatic instruments are designed to minimize laceration or perforation of the tissue even when required retraction is exerted. Due to differences in anatomy of the site and types of surgical procedures, a variety of configurations and models are offered to provide the surgeon with options to ensure clinical needs are met.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Standard Applied) | Specific Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AAMI TIR12:2010 | Manual Cleaning Validation | Not explicitly stated in the provided text. This standard covers "Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers," implying the device must be effectively cleanable to specified levels. | Pass |
| AAMI TIR30:2011 | Automated Cleaning Validation | Not explicitly stated in the provided text. This standard refers to "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices," implying the device must be effectively cleanable to specified levels. | Pass |
| ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012 | Pre-Vacuum Steam Sterilization Validation (270°F (132°C) for 4 minutes) | Not explicitly stated in the provided text. This standard is a "Comprehensive guide to steam sterilization and sterility assurance in health care facilities," suggesting the device must withstand and be effectively sterilized by this method without degradation or compromise. | Pass |
| ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012 | Gravity Displacement Steam Sterilization Validation (270°F (132°C) for 15 minutes) | Not explicitly stated in the provided text. This standard is a "Comprehensive guide to steam sterilization and sterility assurance in health care facilities," suggesting the device must withstand and be effectively sterilized by this method without degradation or compromise. | Pass |
| ASTM F 1089-02 | Corrosion Testing | Not explicitly stated in the provided text. This standard is for the "Corrosion of Surgical Instruments," implying the device must demonstrate resistance to corrosion under specified test conditions. | Pass |
| ISO 13402:1995 | Corrosion Testing (implied) | Not explicitly stated in the provided text. This standard covers "Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure," suggesting the device must demonstrate resistance to corrosion and thermal degradation during autoclaving. | Pass (Corrosion covered by ASTM F 1089-02, thermal exposure implicitly covered by sterilization tests) |
| ASTM F 899-11 and ISO 7153-1:2001 | Biocompatibility (Material Selection) | The material, Stainless Steel AISI 420, is recognized as suitable for surgical instruments per these standards and has a long history of safe and effective use. This serves as the acceptance criterion for biocompatibility, eliminating the need for specific biocompatibility testing. | No specific biocompatibility testing was performed, but the material was deemed acceptable based on standards and historical use. |
Important Note: The provided 510(k) summary does not explicitly detail the specific quantitative acceptance criteria (e.g., "bacterial reduction of X logs," "no visible corrosion after Y cycles") for each test. It only states that the device "Passed," implying it met the criteria defined within those standards.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a pre-market notification for a medical device (Integra® Gynecological Forceps) which is a mechanical surgical instrument, not an AI or software-based device. Therefore, the concept of a "test set" in the context of data for AI algorithms is not applicable here.
The "test set" for this device comprises physical samples of the Integra® Gynecological Forceps that underwent various non-clinical performance and material validation tests (cleaning, sterilization, corrosion). The document does not specify the exact number of physical samples used for each test. All tests are prospective as they were conducted specifically for this 510(k) submission. The provenance of the data is from Integra York PA, Inc. (the manufacturer's internal testing or contracted labs).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not an AI or diagnostic device that requires expert ground truth labeling. The "ground truth" for a physical instrument is its functional performance, which is objectively measured against engineering and regulatory standards (e.g., "does it corrode?", "can it be sterilized?"). The experts involved would be engineers, microbiologists, and other technical specialists conducting and evaluating the tests, but not in the sense of establishing a "ground truth" for a classification task.
4. Adjudication Method for the Test Set
Not applicable. There is no subjective interpretation or classification that would require an adjudication method like 2+1 or 3+1. The tests yield objective "Pass" or "Fail" results against predefined criteria in the referenced standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a physical surgical instrument, not a diagnostic imaging or AI-assisted system. MRMC studies are used to evaluate the effectiveness of diagnostic devices on human performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective performance metrics and material compliance as defined by recognized industry and regulatory standards (AAMI, ASTM, ISO). For example:
- Cleaning: The ability to be thoroughly cleaned, likely measured by residual protein/bioburden levels after a cleaning cycle (criteria within AAMI TIR12 and TIR30).
- Sterilization: The ability to withstand sterilization processes without damage and achieve sterility (criteria within ANSI/AAMI ST79).
- Corrosion: Resistance to corrosion under specified conditions (criteria within ASTM F 1089-02 and ISO 13402).
- Biocompatibility: Conformance to established material standards (ASTM F899-11, ISO 7153-1) for surgical instruments made of stainless steel known to be safe in the body.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set for an AI/ML model.
§ 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.