(101 days)
Preamendment, K092840, Preamendment
Not Found
No
The device description and performance studies focus on the mechanical function and sterilization of surgical forceps, with no mention of AI or ML.
No.
The device is a surgical instrument used to manipulate tissue during gynecological procedures, but it does not directly treat a disease or condition itself.
No
The device description indicates that Integra® Gynecological Surgical Forceps are used for "pulling, grasping, holding, or compressing tissue during gynecological procedures," and are "designed to minimize laceration or perforation of the tissue." These are operative actions, not diagnostic ones. Diagnostic devices aim to identify or assess a medical condition.
No
The device is described as hand-held instruments with dual blades, indicating a physical hardware device, not software. The performance studies also focus on cleaning and sterilization validation, which are relevant to physical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the forceps are "hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures." This describes a surgical instrument used directly on the patient's tissue during a procedure.
- Device Description: The description further reinforces this by detailing its use in "vaginal and abdominal hysterectomy procedures" and its design for "providing a secure grip on tissue."
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. The description of the Integra® Gynecological Surgical Forceps does not mention any interaction with specimens or analysis of biological samples.
Therefore, the Integra® Gynecological Surgical Forceps are a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
Product codes (comma separated list FDA assigned to the subject device)
HCZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
Preamendment, K092840, Preamendment
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 1
510(k) Summary
APR : 1 2014
| Submitted by: | Integra York PA, Inc. |
|---|---|
| 589 Davies Drive | |
| York, PA 17402 USA | |
| Contact Person: | Ruthanne Vendy |
| Regulatory Affairs Manager | |
| Integra York PA, Inc. | |
| 589 Davies Drive, York, PA 17402 USA | |
| Phone: (717) 757-7974 | |
| Date Prepared: | January 31, 2014 |
| Device Trade Name: | Integra® Gynecological Forceps |
| Brands: | Jarit®, Miltex®, and MeisterHand® |
| Device Common Name(s): | Gynecological Forceps; Vulsellum Forceps; Uterine Vulsellum |
| Forceps; Tumor Forceps; Uterine Elevating Forceps; Hysterectomy | |
| Forceps; Uterine Artery Forceps; Membrane Puncturing Forceps; | |
| Placenta Forceps; Uterine Polyps Forceps; Forceps; Clamp | |
| Classification Name: | Forceps, Surgical, Gynecological |
| Device Class: | Class II |
| Product Code: | HCZ |
| CFR Classification: | 21 CFR 884.4530 |
Device Description:
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.
Indications For Use:
Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
1
Predicate Devices:
| Device | Manufacturer | |
|---|---|---|
| Preamendment | Miltex® Gynecological Forceps | E. Miltenberg, Inc. |
| K092840 | Forceps Obstetrical/Gynaecological | Instrumed International, Inc. |
| Preamendment | Miniclamps, Stabiliz, Fallopian Tube | Sklar Corporation |
Technological Comparison of Subject Devices to Predicates:
| Integra York PA, Inc.
Gynecological Forceps | E. Miltenberg, Inc.
(now Integra York
PA, Inc.)
Gynecological
Forceps | Instrumed
International, Inc.
OB/GYN Forceps | Sklar Corporation
Gynecological
Forceps | |
|------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 510(k) # | Subject of Submission | Preamendment | K092840 | Preamendment |
| Class | II | II | II | II |
| Pro Code | HCZ | HCZ | HCZ | HCZ |
| Regulation # | 884.4530 | 884.4530 | 884.4530 | 884.4530 |
| Classification | Obstetric-gynecologic
manual instrument | Obstetric-gynecologic
manual instrument | Obstetric-gynecologic
manual instrument | Obstetric-gynecologic
manual instrument |
| Intended Use | used to pull, grasp, or
compress during
gynecological
examination | used to pull, grasp, or
compress during
gynecological
examination | used to pull, grasp, or
compress during
gynecological
examination | used to pull, grasp, or
compress during
gynecological
examination |
| Patient
Contact
Materials | Stainless steel | Stainless steel | Stainless steel | Stainless steel |
| Malleability | Non-malleable | Non-malleable | Non-malleable | Non-malleable |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Sterilization | Sterilizable | Sterilizable | Sterilizable | Sterilizable |
| Utility | Reusable | Reusable | Reusable | Reusable |
| Energy
Source | N/A (manual) | N/A (manual) | N/A (manual) | N/A (manual) |
| Device Sizes | Varied | Varied | Varied | Varied |
| Components | 1-piece | 1-piece | 1-piece | 1-piece |
| Substantially
Equivalent | N/A | Yes1 | Yes1 | Yes1 |
1 Evaluative Statement: These devices are completely comparable to the predicate instruments. There are no significant differences in lechnology, intended use, or design between the predicates selected. The minor differences between patterns have no impact on equivalence.
Performance Standards:
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the following standards were used to assess the Integra® Gynecological Forceps:
- . AAMI TIR12:2010 - Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- . AAMI TIR30:2011 - A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
2
- ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012 Comprehensive guide to steam . sterilization and sterility assurance in health care facilities
- . ASTM F 899-11 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
- . ASTM F 1089-02 - Standard Test Method for Corrosion of Surgical Instruments
- ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance . against autoclaving, corrosion and thermal exposure
- . ISO 7153-1:2001 - Surgical instruments -- Metallic materials -- Part 1: Stainless steel
| Non-Clinical Testing Performed | Results |
|---|---|
| Manual Cleaning Validation | Pass |
| Automated Cleaning Validation | Pass |
| Pre-Vacuum Steam Sterilization Validation at 270°F (132°C) for 4 minutes | Pass |
| Gravity Displacement Steam Sterilization Validation at 270°F (132°C) for 15 minutes | Pass |
| Corrosion Testing | Pass |
No biocompatibility testing was performed on the proposed devices, as stainless steel AISI 420 is recognized as a suitable stainless steel for surgical instruments per ASTM F899-11 and ISO 7153-1. AlSI 420 has a long history of safe and effective use, and has been used in other medical devices that have been cleared by the FDA (e.g., K971977).
Conclusions drawn from Non-Clinical Data:
All necessary testing has been performed on the Integra® Gynecological Forceps and the results support the conclusion that the subject devices are substantially equivalent to the legally marketed predicate devices based on intended use, materials, technology, and design and as such, do not raise any concerns of safety or effectiveness.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized eagle emblem. The eagle is depicted with three curved lines representing its body and wings. The text is in all caps.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2014
Integra LifeSciences Corporation Integra York PA, Inc. Ruthanne Vendy, RAC Regulatory Affairs Manager 589 Davies Drive York, PA 17402
Re: K134047
Trade/Device Name: Integra® Gynecological Forceps Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HCZ Dated: January 28, 2014 Received: February 3, 2014
Dear Ruthanne Vendy,
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.
4
Page 2 - Ruthanne Vendy, RAC
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Image /page/4/Picture/7 description: The image shows the name "Herbert P. Lerner - S" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is easy to read. The text appears to be a signature or a nameplate.
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
5
Indications for Use
K134047 510(k) Number (if known):
Integra® Gynecological Forceps Device Name:
Indications for Use:
Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
Prescription Use_ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 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)
Herbert P. Lerner 2014.04.11 15:35:24 -04'00'
Image /page/5/Picture/11 description: The image shows the word "INTEGRA" in bold, black letters. Below the word, there is some smaller text that is difficult to read. To the right of the word, there is a small graphic that appears to be a collection of squares and circles.