(15 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical tenaculum, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is described as a tenaculum, which is an instrument used to grasp, hold, and manipulate tissue, not to treat a disease or condition. Its intended use is mechanical manipulation rather than therapeutic intervention.
No
Explanation: The device description states its intended use is to "Snare, grasp, hold and manipulate cervical and intravaginal tissue." This describes a surgical tool used for physical intervention or manipulation, not for diagnosing a condition or disease. The performance studies focus on the structural integrity and biocompatibility of the device, not on its ability to provide diagnostic information.
No
The device description explicitly states it is made of glass reinforced polycarbonate and is a physical instrument (tenaculum) used to grasp and manipulate tissue. It undergoes physical performance testing and sterilization validation, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Snare, grasp, hold and manipulate cervical and intravaginal tissue." This describes a physical manipulation of tissue within the body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical instrument made of polycarbonate, designed for direct interaction with tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on the physical strength, flexibility, and biocompatibility of the device, which are typical for surgical or gynecological instruments, not IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This device does not fit that description.
N/A
Intended Use / Indications for Use
To snare, grasp, hold and manipulate cervical and intravaginal tissue.
Product codes (comma separated list FDA assigned to the subject device)
HDC
Device Description
GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical and intravaginal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The advanced composite design can easily withstand forces during normal use as evidenced by performance testing.. In these reports non sterile, gamma sterilized non-aged, and gamma sterilized aged product were tested in four ways to determine strength and weakness in their construction. The first report determined the flexibility and the strength of the arms, the second determined the strength of the tips, and the third report determined the strength of the rack and the force needed to lock the instrument during use. The final report determined the strength of the hinge pin. All test reports showed that the instrument met the minimum acceptance criteria. These tests proved that the material does not degrade because of gamma sterilization and extended shelf life. Another test was done to determine the maximum perceived force during normal use by a physician using a stainless steel tenaculum.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
Submitted By:
GYN Disposables, Inc. 2671 Appling Road Memphis, TN 38133 Tel: 901.372.6181 Fax: 901.213.0957
NOV 2 8 2007
1
Contact: James K. Patterson, MD, MBA
Device Classification Name: Tenaculum, Uterine
Device Name: GYN Disposables, Inc. Tenaculum 356T
Classification: 884.4530 Obstetric-gynecologic specialized manual instrument ... (15) A Uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
Device Class: Class II
Classification Panel: Ob/Gyn Device Panel
Classification Product Code: HDC
Establishment Registration Number: 3006365741
Indication for Use: To snare, grasp, hold and manipulate cervical and intravaginal tissue.
Device Description: GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.
1
Substantial Equivalence: Atraumatic Tenacula (K930037) and Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum (K980247) are predicate devices.
| | GYN Disposables | Thomasville Medical | Gynex Corp
Iris Hook
Angle Hook |
|------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Tenaculum 356T | Atraumatic Tenaculum | Emmett Tenaculum |
| 510(K) Number | N/A | K930037 | K980247 |
| Product Code | HDC | HDC | HDC |
| Indications for
use | Snare, grasp, hold and
manipulate
cervical and intravaginal
tissue | Snare, grasp, hold and
manipulate
cervical and intravaginal
tissue | Snare, grasp, hold and
manipulate
cervical and intravaginal
tissue |
| Design | Two Tips grasp cervical and
intravaginal tissue
Handle with two finger holes
Ratcheting lock | Two Tips grasp cervical and
intravaginal tissue
Handle with two finger holes
Ratcheting lock | Single tip grasp cervical and
intravaginal tissue
Single Rod |
| Material | Glass Reinforced Polycarbonate | 302 Stainless Steel | 302 Stainless Steel |
| Sterilization | Purchased Sterile (gamma) | Clean only | Clean only |
| Single use | Yes | No | No |
Material Specifications: GYN Disposables Tenaculum 356T is made with glass reinforced polycarbonate. The advanced composite design can easily withstand forces during normal use as evidenced by performance testing.. In these reports non sterile, gamma sterilized non-aged, and gamma sterilized aged product were tested in four ways to determine strength and weakness in their construction. The first report determined the flexibility and the strength of the arms, the second determined the strength of the tips, and the third report determined the strength of the rack and the force needed to lock the instrument during use. The final report determined the strength of the hinge pin. All test reports showed that the instrument met the minimum acceptance criteria. These tests proved that the material does not degrade because of gamma sterilization and extended shelf life. Another test was done to determine the maximum perceived force during normal use by a physician using a stainless steel tenaculum.
Biocompatibility: The material used by GYN Disposbables, Inc. to make the subject device is a glass-reinforced polycarbonate. This material is made into an OB/GYN instrument called a Tenaculum and is gamma sterilized. The material used is classified by the Rubber And Plastic Research Association (RAPRA) as 43C12 for polycarbonate and 6272 as glass-reinforced. Even though this material or its components have been used in other medical applications and these instruments are only used once and only briefly contacts the patient, GYN Disposables has carried out seven biocompatibility tests on the as-molded, as-sterilized finished instrument.
2
The first test was an in vitro cytotoxicity test using the following method: the test article was put into the extraction media for not less than 24 hours. The media was incubated for 48 hours and examined for biological activity. Relative to positive and negative controls, the test article did not induce cytotoxicity.
The second test was a similar test except that the extraction was intravenously injected into rabbits. The temperatures of the rabbits were measured for up to 3 hours. This test, called a pyrogen test, in essence is a sensitization and irritation indicator for use of the instrument. These tests found that the as-made instrument did not cause any increase in temperature.
The third test was a hemolysis test. Extracts from the instrument were again made and combined with fresh, whole, rabbit blood using a process that takes approximately 2 hours. The average % hemolysis was determined to be 0.0%, meaning that the extract did not cause damage to blood cells.
In addition to these three tests, four in vivo tests of toxicity were also performed-dermal sensitization in a guinea pig, systemic toxicity in a mouse, and two types of irritation testing (one intracutaneous [between the layers of the skin] and one vaginal) both in rabbits. In all four tests the GYN material passed. Duration of contact of tissue for cytotoxicity, and systemic toxicity was 24, 48, and 72 hours. Contact for Intercutaneous irritation test was 72 hours, vaginal irritation 24 hours for five consecutive days, and systemic toxicity for 1, 1.5, 2, 2.5, and 3 hours.
These seven tests meet and exceed the criteria established in Table 1 in the FDA's 510(k) Memorandum #G95 (dated May 1, 1995) as follows. The disposable Tenaculum instrument has minimal contact duration with the patient and therefore meets Category A (