(245 days)
Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
This 510(k) covers 31 devices a total of 132 variants representing three general designs (vulsellum, tenaculum, and hysterectomy). These products are reusable manual surgical instruments to be used in gynecological procedures. They are scissor-like, self-retaining devices with ring handles and two blades and made of high-grade stainless steel or titanium. They are available in various sizes with different blade designs at the distal end (e.g., straight or curved). Some of these devices have an additional grasping claw at the distal end. The blades are heavily serrated or may have a profiled longitudinal groove to provide extra grip of the organ.
The subject devices vary in the jaw configurations and curvature to meet the surgeon's needs and preferences, based on individual, anatomical variations of the patients. The products are sold nonsterile and can be reused (cleaned and sterilized) according to the instructions for use.
This document does not describe "acceptance criteria" for a device in the context of clinical performance metrics (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating "substantial equivalence" of a new medical device to a predicate device for FDA clearance. The "performance criteria" described are engineering and biocompatibility tests rather than clinical study endpoints.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as it pertains to a 510(k) premarket notification for a manual surgical instrument, not an AI/software device that would typically have such performance criteria.
Here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet G.P. requirements for patient safety | Cytotoxicity testing per ISO 10993-5:2009 was performed. Biocompatibility information from cleared devices (K160104, K150468, and K120492) was leveraged. (Implicitly, the device passed these tests to support substantial equivalence). |
| Cleaning & Sterilization Validation | Meet requirements for reprocessing | Cleaning and sterilization validation study performed to meet requirements in: |
- FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015)
- AAMI TIR12:2010. (Implicitly, the device's reprocessing instructions were validated and met these requirements). |
| Boiling Water Test for Corrosion | No evidence of corrosion | Performed per ASTM F1089-10. (Implicitly, the device met the criteria and showed no unacceptable corrosion). |
| Elasticity Test | Maintain functional elasticity | Performed per DIN 96198-3. (Implicitly, the device met the criteria for elasticity). |
| Functional Equivalence | Perform as intended for its use | The device is demonstrated to have the "same intended use and fundamental technological characteristics" as the predicate device. Differences in material (titanium vs. stainless steel) or specific dimensions were deemed not to raise different questions of safety and effectiveness as titanium is widely used and both devices offer ranges of configurations. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified for any of the non-clinical tests. This typically refers to the number of devices or material samples tested.
- Data Provenance: The tests are described as "non-clinical performance testing" and involved laboratory studies, not patient data. Therefore, country of origin or retrospective/prospective is not applicable in the usual sense for clinical studies. The tests were performed in support of the device's substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a manual surgical instrument. "Ground truth" in the context of expert consensus is not relevant here; the ground truth is established by standardized material and performance testing.
4. Adjudication method for the test set
- Not applicable. This is for non-clinical, objective performance tests, not subjective interpretations requiring adjudication.
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 is not an AI or software device.
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
- For Biocompatibility: The "ground truth" is adherence to ISO standards and established biocompatibility principles.
- For Cleaning & Sterilization Validation: The "ground truth" is the ability to render the device clean and sterile according to FDA guidance and AAMI standards.
- For Bench Performance Tests (Corrosion, Elasticity): The "ground truth" is the physical properties of the materials and device and its performance against established engineering standards (ASTM, DIN).
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.