Fetzer Medical Gynecological Forceps

K172661 · Fetzer Medical GmbH & Co. KG · HCZ · May 8, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K172661
• Device Name: Fetzer Medical Gynecological Forceps
• Applicant: Fetzer Medical GmbH & Co. KG
• Product Code: HCZ · Obstetrics/Gynecology
• Decision Date: May 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.

Device Story

Fetzer Medical Gynecological Forceps are reusable, manual, scissor-like surgical instruments; available in vulsellum, tenaculum, and hysterectomy designs. Devices feature ring handles, dual blades, and varying jaw configurations (straight/curved, serrated, or grooved) to accommodate anatomical variations. Used by surgeons in gynecological procedures to manipulate tissue. Devices are sold non-sterile and require cleaning and steam sterilization by the user between procedures. Benefit includes providing secure tissue grip during surgery.

Clinical Evidence

Bench testing only. Testing included cytotoxicity (ISO 10993-5:2009), corrosion resistance (ASTM F1089-10), elasticity (DIN 96198-3), and validation of cleaning and steam sterilization per FDA guidance and AAMI TIR12:2010.

Technological Characteristics

Manual, reusable surgical instruments. Materials: stainless steel or titanium. Design: scissor-like, ring-handled, dual-blade. Configurations: vulsellum, tenaculum, hysterectomy; various sizes, curvatures, and serrations. Standards: ASTM F1089-10 (corrosion), DIN 96198-3 (elasticity), ISO 10993-5 (biocompatibility). Sterilization: steam.

Indications for Use

Indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures in patients requiring such surgical intervention.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Integra Gynecological Forceps (K134047)

Reference Devices

• K160104
• K150468
• K120492

Submission Summary (Full Text)

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May 8, 2018

Fetzer Medical GmbH & Co. KG Harald Jung Manager Quality/Regulatory Affairs Unter Buchsteig 5 Tuttlingen, Baden-Wuerttemberg 78532 Germany

Re: K172661

Trade/Device Name: Fetzer Medical Gynecological Forceps Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: HCZ Dated: April 6, 2018 Received: April 10, 2018

Dear Harald Jung:

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.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and simple.

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172661

Device Name Fetzer Medical Gynecological Forceps

Indications for Use (Describe)

Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> ☒ </span> </div> |
|----------------------------------------------|-------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> ☐ </span> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Fetzer Medical. The logo is in gray, with the word "Fetzer" in a stylized font. A blue swoosh appears above the "t" in Fetzer. Below the word "Fetzer" is the word "MEDICAL" in smaller, gray letters.

# 510(k) Summary (K172661)

#### 1. Submitter Information

| Submitter: | Fetzer Medical GmbH & Co. KG<br>Unter Buchsteig 5<br>D-78532 Tuttlingen<br>GERMANY |
|-----------------|------------------------------------------------------------------------------------|
| Contact Person: | Harald Jung, Manager Quality & Regulatory |
| Phone: | [phone] |
| Fax: | [phone] |

- 2. Date Prepared May 7, 2018
#### 3. Device Information

| Trade Names: | Fetzer Medical Gynecological Forceps | |
|--------------------|------------------------------------------------------------|--|
| Common Name: | Vulsellum Forceps, Tenaculum Forceps, Hysterectomy Forceps | |
| Regulation Number: | 21 CFR 884.4530 | |
| Regulation Name: | Obstetric-Gynecologic Specialized Manual Instrument | |
| Product Code: | HCZ (Forceps, Surgical, Gynecological) | |
| Regulatory Class: | II | |

### 4. Predicate Device:

Integra ® Gynecological Forceps (K134047) manufactured by Integra Lifesciences Corporation. The predicate device has not been subject to any design related recalls.

### 5. Device Description:

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.

#### 6. Indications for Use

Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.

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Image /page/4/Picture/0 description: The image shows the logo for Fetzer Medical. The word "Fetzer" is written in a stylized, sans-serif font, with a blue swoosh above the "t". Below the word "Fetzer", the word "MEDICAL" is written in a smaller, sans-serif font. The logo is simple and modern, and the use of blue suggests a connection to healthcare.

# 7. Comparison of Intended Use and Technological Characteristics of the Subject Device and Predicate Device

| Device: | K172661 - Subject device | K134047 - Predicate device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Fetzer Medical Gynecological<br>Forceps are hand-held instruments<br>with dual blades that are indicated<br>for pulling, grasping, holding, or<br>compressing tissue during<br>gynecological procedures. | Integra gynecological surgical forceps<br>are hand-held instruments with dual<br>blades that are indicated for pulling,<br>grasping, holding, or compressing tissue<br>during gynecological procedures. |
| General design | Same as the predicate device | Vulsellum, tenaculum, and hysterectomy |
| Device version | Same as the predicate device | Multiple variants for each general design |
| Dimensions | Same as the predicate device | Ranged for each general design |
| Jaw configuration | Same as the predicate device | Ranged for each general design |
| Curvature | Same as the predicate device | Ranged for each general design |
| Material | Stainless steel or titanium | Stainless steel |
| Reprocessing step | Same as the predicate device | Cleaning and steam cycle |

The subject and predicate devices have the same intended use for pulling, grasping, holding, or compressing tissue during gynecological procedures.

The subject and predicate devices have multiple variants representing the same general designs (vulsellum, tenaculum, and hysterectomy) and comparable reprocessing procedures. There are differences in dimensions, jaw configuration and curvature between the subject and predicate devices. However, these differences in technological characteristics do not raise different questions of safety and effectiveness. In fact, both have ranges of dimensions, jaw configuration and curvature to meet different clinical needs.

One version of the subject devices is manufactured titanium, but the predicate device is not. This difference does not raise different questions of safety and effectiveness, as titanium is widely used in surgical devices.

The differences between the subject and predicate devices can be evaluated by biocompatibility information and bench performance testing.

### 8. Summary of Non-Clinical Performance Testing

The following studies have been performed to support substantial equivalence to the predicate device:

- Cytotoxicity testing per ISO 10993-5:2009
- Cleaning and sterilization validation study to meet the requirements in the following ● documents:
- FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation O Methods and Labeling" issued March 17, 2015
- AAMI TIR12:2010 o
- Bench performance tests: ●
- Boiling water test for corrosion per ASTM F1089-10 o
- Elasticity test per DIN 96198-3 O

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Image /page/5/Picture/0 description: The image shows the logo for Fetzer Medical. The word "Fetzer" is written in a sans-serif font, with a blue swoosh above the "t". Below the word "Fetzer" is the word "MEDICAL" written in a smaller sans-serif font. The logo is simple and modern, and the blue swoosh adds a touch of color and visual interest.

In addition, the biocompatibility information provided in cleared devices (K160104, K150468, and K120492) were leveraged in the current submission to support substantial equivalence to the predicate device.

## 9. Conclusion

The subject and predicate devices have the same intended use and fundamental technological characteristics. The differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.